On February 6, 2012, the FAA published a final rule in the Federal Register amending the airport name and geographic coordinates of Gerald R. Ford International Airport, Grand Rapids, MI, to match the FAA's aeronautical database (77 FR 5691) Docket No. FAA-2011-1406. The Class C airspace designation was published without including the city name.

Accordingly, pursuant to the authority delegated to me, the legal description for the Gerald R. Ford International Airport, Grand Rapids, MI, Class C airspace, as published in the Federal Register of February 6, 2012 (77 FR 5691) (FR Doc. 2012-2485), is corrected as follows:

On page 5692, column 3, lines 50 and 51, remove “AGL MI C Gerald R. Ford International Airport, MI”, and insert: “AGL MI C Grand Rapids, Gerald R. Ford International Airport, MI.”

On page 5692, column 3, lines 52 and 53, remove “Gerald R. Ford International Airport, Grand Rapids, MI”, and insert: “Grand Rapids, Gerald R. Ford International Airport, MI.”

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, April 5, 2012.

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the 1976 amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to previous marketed devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.

Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification (section 513(f)(2) of the FD&C Act).

In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on February 14, 2011, classifying the RIDASCREEN® Norovirus 3rd Generation EIA into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device that was subsequently reclassified into class I or class II. On February 16, 2011, Lehnus and Associates Consulting, on behalf of R-Biopharm AG, submitted a petition requesting classification of the RIDASCREEN® Norovirus 3rd Generation EIA under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.

The device is assigned the generic name norovirus serological reagents, and this device type is identified as devices that consist of antigens and antisera used in serological tests to detect the presence of norovirus antigens in fecal samples. These devices aid in the diagnosis of norovirus infection in the setting of an individual patient with symptoms of acute gastroenteritis when the individual patient is epidemiologically linked to other patients with symptoms of acute gastroenteritis and/or aid in the identification of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting of epidemiologically linked patients with symptoms of acute gastroenteritis.

FDA has identified the risks to health associated with this type of device as a false negative result and a false positive result. A false positive test result for an individual may lead to a potential delay in needed antibiotic treatment (when appropriate) and possibly less thorough laboratory evaluation for the true cause of illness; in the setting of an outbreak investigation, a false positive result may lead to unnecessary environmental interventions and/or significant patient restrictions. A false negative test result for an individual may lead to potentially unnecessary treatment for other causes of acute gastroenteritis, including possible antibiotic exposure; in the setting of an outbreak, a false negative result may lead to delay in recognizing the cause of the outbreak and additional spread of norovirus infection.

FDA has identified the following recommended mitigation measures to address these risks to health associated specifically with this type of device.

Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices. FDA believes that the special controls guidance document, in addition to general controls, addresses the risks to health identified previously and provides reasonable assurance of the safety and effectiveness of the device. Therefore, on February 23, 2011, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this device by adding § 866.3395.

Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a norovirus serological reagents will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined because of the risks of false positives and false negatives that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, this type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the norovirus serological reagents they intend to market.

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

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (Pub. L. 96-354) (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule is deregulatory and imposes no new burdens, the Agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different or in addition to” certain federal requirements applicable to devices. 21 U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls established by this rulemaking create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

This final rule establishes as special controls a guidance document that refers to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” The notice contains an analysis of the paperwork burden for the guidance.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from R-Biopharm AG, c/o Lehnus and Associates, dated February 15, 2011.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

The Pension Benefit Guaranty Corporation published a final rule document in the Federal Register of September 15, 2011 (at 76 FR 56973), amending its regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under those regulations. The rule inadvertently misstated the prescribed interest assumptions under the allocation regulation, applicable to plans with valuation dates during the fourth quarter of 2011. The errors appeared both in the preamble and in the amendatory instructions.

In the preamble, the first full paragraph in the second column on p. 56974 should have read as follows:

In consideration of the foregoing, 29 CFR part 4044 is corrected by making the following correcting amendment:

The Pension Benefit Guaranty Corporation published a final rule document in the Federal Register of June 15, 2011 (at 76 FR 34847), amending its regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under those regulations. The rule inadvertently misstated the prescribed interest assumptions under the allocation regulation, applicable to plans with valuation dates during the third quarter of 2011. The errors appeared both in the preamble and in the amendatory instructions.

In the preamble, the third full paragraph in the second column on p. 34847 should have read as follows:

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

As this interim rule will be in effect before the end of the comment period, the Coast Guard will evaluate and revise this rule as necessary to address significant public comments.

If you submit a comment, please include the docket number for this rulemaking (USCG-2012-0084), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Proposed Rule” and insert “USCG-2012-0084” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change this rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2012-0084” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

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

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

The Coast Guard is issuing this temporary interim rule without prior Federal Register notice 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 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 immediate action is necessary to ensure the safety of the public during construction of the existing Little Bay Bridge. The need for waterway closures was not brought to the attention of the Coast Guard until January 30, 2012 when the New Hampshire Department of Transportation (NHDOT) requested a complete waterway closure for an eight and a half hour period tentatively scheduled for April 10, 2012.

The Coast Guard discussed with NHDOT a number of alternatives to complete waterway closure, including delaying this portion of construction to allow the Coast Guard to publish a notice of proposed rulemaking with respect to this rule, rerouting traffic through an alternate channel, or arranging the construction barges and cranes in a manner that leaves a portion of the main channel navigable. A delay until at least the middle of May would unnecessarily prolong construction and increase costs to the public. In addition, the construction operations are currently ongoing, and construction barges and cranes are already in place. Delaying bridge repairs to allow for a full notice and comment period while repair equipment is already in place is contrary to the public interest due to increased cost to taxpayers. Furthermore, facilitating a waterway closure to allow bridge repairs before recreational boater traffic escalates in May is in the public's interest because it will reduce the impact of the waterway closure on the public.

For the reasons discussed, delaying the project would be contrary to the public interest. For the same reasons, 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 .

Under the Ports and Waterways Safety Act, the Coast Guard has the authority to establish RNAs in defined water areas that are determined to have hazardous conditions and in which vessel traffic can be regulated in the interest of safety. See 33 U.S.C. 1231 and Department of Homeland Security Delegation No. 0170.1.

The purpose of this temporary interim rule is to ensure the safe transit of vessels in the area, and to protect persons, vessels, and the marine environment during construction operations for the duration of the Little Bay Bridge construction.

The construction of the Little Bay Bridge involves large machinery and construction vessel operations on and over the navigable waters of Little Bay in the Piscataqua River. The ongoing operations are hazardous by their nature, and pose risks both to recreational and commercial traffic, as well as to the construction crew. In order to mitigate the inherent risks involved in construction, it is necessary to control vessel movement through the area.

The purpose of this temporary interim rule is to ensure the safe transit of vessels in the area, and to protect persons, vessels, and the marine environment during construction operations for the duration of the Little Bay Bridge construction work through July 31, 2013.

Heavy-lift operations are sensitive to water movement, and wake from passing vessels could pose significant risk of injury or death to construction workers. In order to minimize such unexpected or uncontrolled movement of water, the RNA will limit vessel speed and wake of all vessels operating in the vicinity of the bridge construction zone. This will be achieved by implementing a five (5) knot speed limit and “NO WAKE” zone in the vicinity of the construction as well as providing a means to suspend all vessel traffic for emergent situations that pose imminent threat to waterway users in the area. The RNA will also protect vessels desiring to transit the area by ensuring that vessels are only permitted to transit when it is safe to do so.

The Coast Guard may close the regulated area described in this rule to all vessel traffic during any circumstance that poses an imminent threat to waterway users operating in the area. Complete waterway closures will be made with as much advanced notice as possible. At present, we expect at least two days when the area will be completely closed, but those days have not yet been scheduled by the project managers.

The Captain of the Port (COTP) Sector Northern New England will cause notice of enforcement to be made by appropriate means to ensure the widest distribution among the affected segments of the public. Such means of notification may include, but are not limited to, Broadcast Notice to Mariners and Local Notice to Mariners. In addition, the COTP maintains a telephone line that is staffed 24 hours a day, seven days a week. The public can obtain information concerning enforcement of the regulated navigation area by contacting Coast Guard Sector Northern New England Command Center at (207) 767-0303.

Entry into the regulated area during a closure is prohibited unless specifically authorized by the Sector Northern New England Captain of the Port (COTP). Any violation of this RNA is punishable by civil and criminal penalties, in rem liability against the offending vessel, and the initiation of suspension or revocation proceedings against Coast Guard-issued merchant-mariner credentials.

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

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

We expect the economic impact of this rule to be minimal because this regulated navigation area only requires vessels to reduce speed through 600 yards of Little Bay, therefore causing only a minimal delay to a vessel's transit. In addition, periods when the regulated navigation area will be closed to all traffic are expected to be short in duration, and the Coast Guard will give advance notice of such closures.

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 substantial number of small entities. This rule will affect the following entities some of which may be small entities: The owners or operators of marinas, charter fishing vessels, commercial fishing vessels, and recreational vessels who intend to transit in those portions of Little Bay beneath the new Little Bay Bridge during the effective period. In addition, periods when the regulated navigation area is closed to all traffic are expected to be short in duration, and the Coast Guard expects to give advance notice of such closures.

This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: It requires vessels to reduce speed through only 600 yards of Little Bay, therefore causing only a minimal delay to a vessel's transit. We will use various appropriate means to inform the public before, during, and at the conclusion of any RNA enforcement period.

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

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such 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 an RNA. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES . Any comments received concerning environmental impacts will be considered and changes made to the environmental analysis checklist and categorical exclusion determination as appropriate.

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

Table of Contents I. Why is the EPA using a direct final rule? II. Does this action apply to me? III. What should I consider as I prepare my comments for the EPA? A. Submitting CBI B. Tips for Preparing Your Comments IV. What are the amendments made by this direct final rule? V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Why is the EPA using a direct final rule?

The EPA is publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. Section 59.511(j) of the final rule states that if a regulated entity identifies a VOC that is needed for an aerosol formulation that is not listed in Tables 2A, 2B, or 2C, it is assigned a default reactivity factor (RF) of 22.04/Z g O 3 /g VOC. However, regulated entities may petition the Agency to add a compound to Table 2A, 2B, or 2C provided that the petitions include the chemical name, CAS number, a statement certifying the intent to use the compound in an aerosol coatings product, and adequate information to evaluate the reactivity of the compound and assign a RF value consistent with the values for the other compounds listed in Table 2A. Since publication of the final rule (73 FR 15604, March 24, 2008), compounds have been added to Table 2A following the same procedure (74 FR 29595, June 23, 2009). The amendments to the aerosol coatings final rule described herein consist of adding three compounds to Table 2A, and their associated RFs and Chemical Abstract Service (CAS) numbers, based on petitions received by the Agency and consistent with Section 59.511(j) of the final rule. The amendments do not make material changes to the rule. This action also revises Table 1 of the final rule by moving the units from the table heading to the reactivity limits column, revises Tables 2A, 2B, and 2C by assigning units to the reactivity factor column, and corrects a typographical error in a test method reference. However, in the “Proposed Rules” section of this Federal Register , we are publishing a separate document that will serve as the proposed rule to the National Volatile Organic Compound Emission Standards for Aerosol Coatings (40 CFR part 59) if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If the EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that some or all of the amendments in this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

The entities potentially affected by this direct final rule are the same entities that are subject to the aerosol coatings final rule. The entities affected by the aerosol coatings final rule include: Manufacturers, processors, distributors or importers of aerosol coatings for sale or distribution in the United States, and manufacturers, processors, distributors or importers who supply the entities listed above with aerosol coatings for sale or distribution in interstate commerce in the United States.

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

B. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

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

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

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

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

• Provide specific examples to illustrate your concerns, and suggest alternatives.

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

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

This direct final rule adds three compounds to Table 2A—Reactivity Factors: dimethyl carbonate, benzotrifluoride, hexamethyldisiloxane, and their corresponding CAS numbers and RFs (see Table A). This action is in accordance with Section 59.511(j) of the final rule which allows regulated entities to petition the Agency to add compounds to Table 2A, 2B, or 2C provided that the petition includes the chemical name, CAS number, a statement certifying the intent to use the compound in an aerosol coatings product, and adequate information to evaluate the reactivity of the compound and assign a RF value consistent with the values for the other compounds listed in Table 2A (73 FR 15604, March 24, 2008; 74 FR 29595, June 23, 2009). EPA received petitions from KOWA America, Raymond Regulatory Resources, Seymour of Sycamore, and 3M, requesting the addition of the three compounds to Table 2A.

This action also revises Table 1 of the final rule by moving the units, expressed as grams of ozone per gram of product (g O 3 /g product), from the table heading to the column titled, “Reactivity Limit”; revises Tables 2A, 2B, and 2C by adding units, expressed as grams of ozone per gram of VOC (g O 3 /g VOC), to the column titled, “Reactivity Factors”; and corrects a test method typographical error by replacing the phrase “California Air Resources Board Method 3-0” in 40 CFR 59.515(a)(1) with “California Air Resources Board Method 310.”

As is the case for the other compounds in Table 2A, the RFs assigned to the three compounds are consistent with the maximum incremental reactivity (MIR) values in California's aerosol coatings regulation (Title 17, California Code of Regulations, Division 3, Chapter 1, Subchapter 8.6, Article 1, § 94700).

In the instance of benzotrifluoride and dimethyl carbonate, their RFs were previously published in the EPA's original proposal for this rule; therefore, the information on their reactivity had been adequately evaluated and RFs assigned (72 FR 38592, July 16, 2007). When the rule was finalized, only those compounds known to EPA to be used in aerosol coating formulations were included in Table 2A (73 FR 15604, March 24, 2008). At the time the original rule was finalized, EPA did not know of any aerosol coating formulations in which benzotrifluoride and dimethyl carbonate were used, so their RFs were not included in Table 2A. The RFs for benzotrifluoride and dimethyl carbonate are consistent with the California MIR values that have been effective since July 18, 2001.

For hexamethyldisiloxane, an RF value was not included in the original proposal for this rule. California assigned an MIR value of zero to hexamethyldisiloxane, effective October 2, 2010. The most recent MIR values published by Dr. William Carter at the University of California at Riverside, upon which the California MIR values are based, lists the MIR for hexamethyldisiloxane as −0.025 g O 3 /g VOC (see http://www.cert.ucr.edu/~carter/SAPRC/scales07.xls ). This MIR value indicates that hexamethyldisiloxane acts as a slight inhibitor to ozone formation. Based on this information, the EPA believes that a RF of zero is appropriate for the purposes of this regulation.

Comments on this direct final action are to be limited to issues directly associated with adding these three compounds, and their associated RFs to Table 2A.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735 October 4, 1993) and is, therefore, not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose any new information collection burden because it serves to add compounds to Table 2A of the rule and make several clarifying edits. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations (40 CFR parts 51 and 59) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0617. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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

For purposes of assessing the impacts of this final rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's regulations at 13 CFR 121.201; (2) a governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

This rule will not impose any requirements on small entities. We have determined that small businesses will not incur any adverse impacts because the EPA is taking this action to amend the aerosol coatings rule by adding compounds to Table 2A of the rule and making several clarifying edits. These amendments do not create any new requirements or burdens, and no costs are associated with these amendments.

We have, therefore, concluded that this final rule will relieve regulatory burden for all affected small entities.

This rule does not contain a federal mandate that may result in expenditures of $100 million or more for state, local and tribal governments, in the aggregate, or the private sector in any one year. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.

This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. In this action, the EPA is amending Table 2A by adding three compounds and their associated reactivity factors, and making several clarifying edits.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action adds compounds and corresponding Chemical Abstract Service numbers and reactivity factors to Table 2A of the aerosol coatings rule, and makes several clarifying edits. Thus, Executive Order 13132 does not apply to this action.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action adds compounds and corresponding Chemical Abstract Service numbers and reactivity factors to Table 2A of the aerosol coatings rule, and makes several clarifying edits. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it is based solely on technology performance.

This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs the EPA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.

This action does not involve technical standards. Therefore, the EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. Further, this action adds compounds to Table 2 of the aerosol coatings rule, and corresponding Chemical Abstract Service numbers and reactivity factors, and makes several clarifying edits.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective June 7, 2012.

For the reasons set out in the preamble, part 59 of title 40, Chapter I of the Code of Federal Regulations is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2007-0158 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 May 8, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2007-0158, by one of the following methods:

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

• Mail: 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 April 20, 2011 (76 FR 22067) (FRL-8869-7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1E7830) by Interregional Research Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540 (on behalf of the Arizona Cotton Research and Protection Council, 3721 East Wier Ave., Phoenix, AZ 85040-2933). The petition requested that 40 CFR 180.1206 be amended by establishing a permanent exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on pistachio. This notice referenced a summary of the petition prepared by the petitioner, IR-4 (on behalf of the Arizona Cotton Research and Protection Council), which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption 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 * * *.” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with FFDCA section 408(b)(2)(D), EPA reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The nature and toxicological profile of Aspergillus flavus AF36, a non-aflatoxin-producing strain of Aspergillus flavus, was described extensively in the Federal Register of July 14, 2003 (68 FR 41535) (FRL-7311-6). “Those health effects data were the basis for establishing the tolerance exemption for Aspergillus flavus AF36 in or on cotton (see the Federal Register of July 14, 2003) and corn (see the Federal Register of March 23, 2011 (76 FR 16297) (FRL-8868-7)) and their food/feed commodities and also for temporary tolerance exemptions for experimental use of Aspergillus flavus AF36 on pistachio (see the Federal Register of May 23, 2007 (72 FR 28868) (FRL-8129-4)) and on corn (see the Federal Register of December 26, 2007 (72 FR 72693) (FRL-8342-1)).” The petitioner has now requested that EPA establish a permanent exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on pistachio by amending 40 CFR 180.1206. EPA reviewed the available data and information in support of this particular action.

Aspergillus flavus AF36 is neither toxic nor infective via the oral and pulmonary routes. EPA has determined that AF36 is practically nontoxic for acute oral effects and slightly toxic for acute inhalation effects. This microbial pesticide has been used for more than a decade in experimental laboratory and field trials and in agricultural practice on cotton in Arizona, California, and Texas without any reports of adverse dermal irritation or hypersensitivity effects. Based on the comprehensive toxicological evaluations set forth in earlier actions establishing tolerance exemptions for Aspergillus flavus AF36 in or on cotton (see the Federal Register of July 14, 2003) and corn (see the Federal Register of March 23, 2011) (also, see Ref. 1), EPA concludes that there are no toxicological endpoints of concern for Aspergillus flavus AF36.

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food exposure. Current uses of Aspergillus flavus AF36 include use in or on cotton and corn. Use on pistachios was also permitted under Experimental Use Permit No. 71693-EUP-1, which expired on December 31, 2011. EPA previously evaluated exposure to residues of Aspergillus flavus AF36 through food, resulting from this microbial pesticide's use as an antifungal agent in or on cotton and corn, in the Federal Register of July 14, 2003 and March 23, 2011. Overall, EPA concluded that human food exposure was not expected with Aspergillus flavus AF36's cotton use and was expected (although likely not above Aspergillus flavus background levels) with Aspergillus flavus AF36's corn use.

As a microbial pesticide for use on pistachio, Aspergillus flavus AF36 is intended for a single broadcast soil application from late May to early July. Once applied to pistachio and after exposure to moisture, Aspergillus flavus AF36 germinates, using the carrier upon which it is placed as a nutrient source, and displaces aflatoxin-producing strains of Aspergillus flavus (Ref. 2). Further, multiple-year studies, which monitored air and soil populations of Aspergillus flavus, including strain AF36, in untreated and treated cotton fields, demonstrated replacement of the naturally occurring aflatoxin-producing Aspergillus flavus with Aspergillus flavus AF36 without an increase in the total population of Aspergillus flavus beyond normal background levels (Refs. 3 and 4). Although residues from the use of pesticides containing Aspergillus flavus AF36 may be present on pistachios at the time of harvest, commodity processing procedures ( e.g., roasting and shelling) may further reduce residues of Aspergillus flavus AF36 (Ref. 5).

Should this microbial pesticide be present on food as a result of the cotton, corn, and/or pistachio uses, the results of an acute oral toxicity and pathogenicity study (see Unit III. of the Federal Register of July 14, 2003, as well as Ref. 1) demonstrated that no toxicity, pathogenicity, and/or infectivity is likely to occur with any exposure level of Aspergillus flavus AF36 resulting from application as an antifungal agent in accordance with good agricultural practices.

2. Drinking water exposure. Similar to the drinking water exposure scenarios described for Aspergillus flavus AF36's cotton and corn uses (see the Federal Register of July 14, 2003 and March 23, 2011) exposure to residues of this microbial pesticide in consumed drinking water, resulting from pesticidal use in or on pistachio, is possible but not likely to be greater than current/existing exposures to Aspergillus flavus strains, which are already present in the environment. Pistachio is grown in an arid environment, which minimizes the potential for transfer of Aspergillus flavus AF36 to surface or ground waters that may be used as sources of drinking water. Moreover, the pesticide is applied only once per growing season at a low rate to non-aquatic sites, and offsite movement is not anticipated since the pesticide is in a granular form. If Aspergillus flavus AF36 were to be transferred to surface or ground waters ( e.g., through runoff) that are intended for eventual human consumption and directed to wastewater treatment systems or drinking water facilities, this soilborne fungus may not survive some of the conditions water is subjected to in such systems or facilities, including chlorination, pH adjustments, and filtration (Refs. 6 and 7).

Should this microbial pesticide be present in drinking water ( e.g., water not subject to treatment systems or facilities) as a result of the cotton, corn, and/or pistachio uses, the results of an acute oral toxicity and pathogenicity study (see Unit III. of the Federal Register of July 14, 2003, as well as Ref. 1) demonstrated that no toxicity, pathogenicity, and/or infectivity is likely to occur with any exposure level of Aspergillus flavus AF36 resulting from application as an antifungal agent in accordance with good agricultural practices.

Non-occupational dermal and inhalation exposure is expected to be minimal to non-existent for the uses of Aspergillus flavus AF36 in or on cotton, corn, and pistachio. As described previously in the Federal Register of July 14, 2003 and March 23, 2011 for Aspergillus flavus AF36's cotton and corn uses, this antifungal agent is to be applied to agricultural sites and not in the proximity of residential areas, schools, nursing homes, or day care facilities. Additionally, the Aspergillus flavus AF36 product to be applied to cotton, corn, and pistachio is in a granular form, thereby minimizing drift even for application methods ( e.g., aerial) that may be more likely to result in offsite pesticide movement and exposure.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance exemption, EPA 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 Aspergillus flavus AF36 to share a common mechanism of toxicity with any other substances, and Aspergillus flavus AF36 does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that Aspergillus flavus AF36 does not have a common mechanism of toxicity with other substances. Therefore, section 408(b)(2)(D)(v) of FFDCA does not apply. For information regarding EPA's efforts to identify chemicals that may 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.

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of exposure (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 that a different margin of exposure (safety) will be safe for infants and children. This additional margin of exposure (safety) is commonly referred to as the Food Quality Protection Act Safety Factor. 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.

In this instance, based on all the available information, EPA concludes that there are no threshold effects of concern to infants, children, or adults when Aspergillus flavus AF36 is used as labeled in accordance with good agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) is necessary to protect infants and children and that not adding any additional margin of exposure (safety) will be safe for infants and children.

Moreover, based on the same data and EPA analysis as presented in this unit, the Agency is able to conclude that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of Aspergillus flavus AF36 when it is used as labeled and in accordance with good agricultural practices as an antifungal agent. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, there appears to be no potential for harm from this fungus in its use as an antifungal agent via dietary exposure since the microorganism is non-toxic and non-pathogenic to animals and humans. EPA arrived at this conclusion based on the very low levels of mammalian toxicity for acute oral and pulmonary effects with no toxicity or infectivity at the doses tested (see Unit III. of this document).

An analytical method is not required for enforcement purposes for the reasons stated in this document and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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

The Codex has not established a MRL for Aspergillus flavus AF36.

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus AF36. Therefore, the existing temporary tolerance exemption for Aspergillus flavus AF36 is amended by establishing a permanent exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on pistachio when applied as an antifungal agent and used in accordance with good agricultural practices.

This final rule amends a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to EPA. 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 amended on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA 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 to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0349 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 May 8, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0349, 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 27, 2010 (75 FR 66092) (FRL-8848-3), 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 9F7661) by Mitsui Chemical Agro, Inc. c/o Landis International Inc., P.O. Box 5126 Valdosta, GA 31603-5126. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide penthiopyrad, (RS)- N -[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on fruit, pome, group 11 at 0.4 parts per million (ppm); apple, wet pomace at 1.0 ppm; fruit, stone, group 12 at 4.0 ppm; low growing berry, subgroup 13-07G at 3.0 ppm; vegetable, bulb, group 3 at 4.0 ppm; vegetable, brassica head and stem, subgroup 5A at 8.0 ppm; vegetable, brassica leafy, subgroup 5B at 45 ppm; vegetable, fruiting, group 8 at 2.5 ppm; tomato, paste at 5.0 ppm; vegetable, cucurbit, group 9 at 1.0 ppm; vegetable, leafy, except brassica, group 4 at 20 ppm; vegetable, root, subgroup 1A at 2.5 ppm; vegetable, tuberous and corm, subgroup 1C at 0.06 ppm; vegetables, leaves of root and tuber, group 2 at 55 ppm; vegetable, edible-podded legume, subgroup 6A at 2.5 ppm; vegetable, succulent, shelled peas and beans, subgroup 6B at 0.4 ppm; vegetable, pea and bean, dried shelled, except soybean, subgroup 6C at 0.3 ppm; soybean, seed at 0.3 ppm; soybean, hulls at 1.0 ppm; peanut, nutmeat at 0.04 ppm; grain, cereal (except corn, millet, sorghum) at 0.2 ppm; corn, field, sweet, pop at 0.01 ppm; corn, refined oil at 0.03 ppm; cereal grain, millet at 0.9 ppm; cereal grain, sorghum at 0.9 ppm; nut, tree, group 14 (including pistachios) at 0.05 ppm; almond, hulls at 6.0 ppm; canola at 1.0 ppm; sunflower at 0.8 ppm; cotton, seed at 0.35 ppm; cotton, gin byproducts at 10 ppm; alfalfa, forage at 10 ppm; alfalfa, hay at 25 ppm; foliage of legume vegetables, group 7, hay at 80 ppm; foliage of legume vegetables, group 7, vines/forage at 30 ppm; peanut, hay at 50 ppm; grain, cereal, group 16, hay at 90 ppm; grain, cereal, group 16, forage at 25 ppm; grain, cereal, group 16, straw at 2 ppm; grain, cereal, stover at 11 ppm and establishing tolerances for residues of penthiopyrad, (RS)- N -[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-pyrazole-4-carboxamide and its major metabolite PAM (1-methyl-3-trifluoromethyl-1 H -pyrazole-4-carboxamide) in animal commodities hog, meat at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.01 ppm; hog, kidney at 0.01 ppm; hog, meat byproducts at 0.01 ppm; cattle, meat at 0.05 ppm; cattle, fat at 0.05 ppm; cattle, liver at 0.2 ppm; cattle, kidney at 0.1 ppm; cattle, meat byproducts at 0.2 ppm; sheep, meat at 0.01 ppm; sheep, fat at 0.02 ppm; sheep, liver at 0.05 ppm; sheep, kidney at 0.02 ppm; sheep, meat byproducts at 0.05 ppm; milk at 0.05 ppm; milk, fat at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, fat at 0.01 ppm; poultry, liver at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; poultry, eggs at 0.01 ppm. That notice referenced a summary of the petition prepared by Mitsui Chemical Agro, Inc. c/o Landis International, 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 several of the proposed tolerance levels. The reasons for these changes are explained in Unit IV.C.

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

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

For penthiopyrad, the liver and thyroid are the target organs. In toxicity studies, short-term oral exposure resulted in liver alterations in rats and mice at similar doses, and in dogs at higher doses. Short-term exposure also resulted in thyroid changes in mice and rats. Other effects observed were body weight changes and hematological alterations in rats and dogs, along with gallbladder effects in dogs. Short-term dermal exposure did not result in dermal irritation or systemic effects up to the limit dose tested.

Long-term exposure in rats resulted in liver effects; adrenal, ovarian, and thyroid hypertrophy; and thyroid tumors. In mice, chronic exposure led to liver and thyroid effects and liver tumors. In dogs, effects noted (liver, gallbladder, and adrenal glands) were similar to those seen in subchronic dog studies, with the addition of more progressive gallbladder effects.

No evidence of increased quantitative or qualitative susceptibility was observed in developmental toxicity studies in rats or rabbits or in a reproduction toxicity study in rats. However, increased quantitative susceptibility was seen in a developmental neurotoxicity (DNT) study in rats. In the DNT, decreased body weight, increased motor activity, and tremors were seen in offspring animals in the absence of maternal toxicity.

Clinical signs (hunched posture, unsteady gait, reduced body temperature, and increased landing foots play) were observed in the acute neurotoxicity study in rats. However, no clinical signs were observed in the subchronic neurotoxicity study in rats. In the immunotoxicity study in mice, decreased plaque forming ability was observed at the limit dose. However, in the immunotoxicity study in rats, no evidence of immunotoxicity was observed up to the highest dose tested. Penthiopyrad has been classified as having “suggestive evidence of carcinogenicity.” Although liver tumors were seen in a cancer study in the mouse, the tumors were only observed at high doses and only noted in one sex and one species. The no-observed-adverse-effect-level (NOAEL) (27 milligrams/kilogram/day (mg/kg)) used for establishing the chronic reference dose is approximately 10-fold lower than the lowest dose (200 mg/kg/day) that induced liver tumors in mice. Based on these factors, including the fact that the only tumors seen were liver tumors in mice, the Agency has determined that the quantification of risk using a non-linear approach will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to penthiopyrad. The EPA received a number of studies for penthiopyrad metabolites, including subchronic oral, mutagenicity studies, etc.; however, none of these studies indicated that metabolites were more toxic than the parent.

Specific information on the studies received and the nature of the adverse effects caused by penthiopyrad as well as the NOAEL and can be found at http://www.regulations.gov in the document “Penthiopyrad. Human Health Risk Assessment for the Section 3 Registration Action on Numerous Agricultural Crops, Turfgrass, and Ornamentals,” starting on page 23 in docket ID number EPA-HQ-OPP-2010-0349.

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 penthiopyrad 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 penthiopyrad, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from penthiopyrad in food as follows:

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

Such effects were identified for penthiopyrad. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA used tolerance-level residues, 100% crop treated assumptions for all commodities, and both default and empirical processing factors.

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 used tolerance-level residues, 100% crop treated assumptions for all commodities, and both default and empirical processing factors.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has determined that quantification using a linear low dose approach was not required, and the chronic dose and endpoint are considered to be protective of cancer effects. Thus, no separate exposure assessment was performed in assessing cancer risk.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for penthiopyrad in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of penthiopyrad. 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), provisional Tier 1 Cranberry and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of penthiopyrad for acute exposures are estimated to be 289 parts per billion (ppb) for surface water and ≤98 ppb for groundwater. For chronic exposures are estimated to be 222 ppb for surface water and ≤98 ppb for groundwater. The surface water estimates were used for both the acute and chronic (non-cancer/cancer) assessments because they were higher than the groundwater estimates. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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

Penthiopyrad is currently registered for the following use that could result in residential exposures: Turfgrass. EPA assessed residential exposure using the following assumptions:

No chemical-specific unit exposure data were provided in support of this submission; therefore, the Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (June 2011) and the Outdoor Residential Exposure Task Force (OREFT) study unit exposures were used to estimate handler exposures. These unit exposures were based on residential handlers wearing short pants, short-sleeved shirt, and no gloves.

Postapplication scenarios include children (1 to 3 years old) playing on treated turf, adults performing yard work on treated turf, and adults playing golf on treated turf. The postapplication scenarios resulting from commercial and residential applications were assessed using default assumptions and transfer coefficients from the EPA Draft SOPs for Residential Exposure Assessments, 2000. As the short- and intermediate-term dermal endpoints are the same for each route of exposure, only short-term dermal exposures were assessed for adults and children. EPA estimates short-term dermal postapplication exposure based on day-0 residues, that is, the residue present on the day of application. Using day-0 residues to assess intermediate-term exposure does not take into account dissipation of residues over time and, thus, results in a conservative estimate. Therefore, the short-term dermal postapplication exposure assessment represents the worst case scenario and is protective of intermediate-term dermal exposure. Additionally, oral non-dietary ingestion exposures were assessed for children (i.e., soil ingestion, and hand-/object-to-mouth). 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 penthiopyrad to share a common mechanism of toxicity with any other substances, and penthiopyrad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that penthiopyrad does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There is no evidence of increased quantitative or qualitative susceptibility in developmental toxicity studies on rats/rabbits or in a reproduction toxicity study on rats. However, there is evidence of increased susceptibility following prenatal/or postnatal exposure in preliminary and definitive DNT studies on rats. Effects include decreased body weight, increased motor activity, and tremors (definitive), as well as mortality (preliminary).

Although increased susceptibility was seen in the DNT studies, the EPA concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of penthiopyrad because:

• The pup body weight changes noted in the definitive and preliminary DNT studies were observed in other developmental/reproduction studies at similar doses. Additionally, the body weight changes in these studies occurred in the presence of significant maternal toxicity and there was no evidence of increased susceptibility. Although clinical signs (tremors and increased motor activity) were noted in offspring animals in the DNT study, the neurotoxic potential of penthiopyrad has been adequately characterized in the available neurotoxicity studies. In the preliminary DNT study, mortality was observed in the offspring animals at the limit dose. However, this finding is attributed to the poor condition (body weight loss, under activity, pallor) of the offspring animals in this dose group.

• Clear NOAELs have been identified for all offspring effects and the risk assessments are based on the most sensitive endpoints. Therefore, the NOAELs selected for risk assessment are protective of potential developmental and offspring effects.

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

i. The toxicity database for penthiopyrad is complete.

ii. There is no concern for neurotoxicity after exposure to penthiopyrad. A complete neurotoxicity battery is available for penthiopyrad. This includes acute neurotoxicity, subchronic neurotoxicity, and DNT studies in rats. As a result, the neurotoxic potential of penthiopyrad is well characterized and no additional data are needed

iii. There is no residual concern regarding increased quantitative or qualitative prenatal and/or postnatal susceptibility for the reasons explained in Unit III.D.2.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to penthiopyrad in drinking water. EPA used similarly conservative assumptions to assess residential exposures, including those of adults applying penthiopyrad and postapplication exposures of adults and children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by penthiopyrad.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to penthiopyrad will occupy 7% of the aPAD for the general U.S. population and 11% of the aPAD for children 1 to 2 years old (the population group receiving the greatest exposure). Since acute aggregate risk results from exposure to residues in food and water alone, the acute aggregate risks are not of concern.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to penthiopyrad from food and water will utilize 11% of the cPAD for the general U.S. population and 19% of the cPAD for children 1 to 2 years old (the population group receiving the greatest exposure). Since there are no residential scenarios that result in long-term exposure to penthiopyrad, the chronic aggregate risks are equivalent to the chronic dietary risks and are not of concern.

3. Short-/intermediate-term risk. Short-/intermediate-term aggregate exposure takes into account short-/intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The short-/ intermediate-term toxicological endpoints for penthiopyrad are the same for each route of exposure. Therefore, for residential exposure scenarios, only short-term exposures were assessed, and are protective of intermediate-term exposure and risk. Penthiopyrad is proposed for registration for uses that could result in short-/intermediate-term residential exposures, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short -term residential exposures to penthiopyrad.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposures result in adult aggregate estimated MOEs of 580 for males and females. Furthermore, although there is the potential for exposure to children resulting from two different routes (i.e. dermal and oral exposure), the toxicological effects from the dermal and oral routes of exposure are different. As a result, a combined residential exposure assessment was not conducted for children. The short-term aggregate risk assessment for children resulted in estimated MOEs of 500 for dermal and 410 for oral exposure. Because EPA's level of concern for penthiopyrad is a MOE of 100 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. Based on the relevant cancer studies EPA has concluded that the pesticide poses no greater than a negligible cancer risk and the chronic dietary risk assessment is protective of cancer effects and, therefore, cancer risk resulting from exposure to penthiopyrad is not of concern.

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 penthiopyrad residues.

Adequate liquid chromatography methods with tandem mass spectrometry (LC/MS/MS) are available to enforce the tolerance expressions for penthiopyrad in plant (Method CEMR 3727 also known as Method CEM 3399-001) and livestock (Methods LDA0082 and LDA0083) matrices.

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; email address: residuemethods@epa.gov.

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

The Codex has not established MRLs for the new active ingredient penthiopyrad.

The EPA has revised several of the proposed tolerance levels. The major reason for the modifications is that the petitioner determined the proposed tolerances using the tolerance calculation procedure utilized by countries in the North American Free Trade Agreement but EPA conducted a joint review of this chemical with the United Kingdom and utilized a similar, but slightly different tolerance calculation procedure followed by the Organization for Economic Co-operation and Development.

Therefore, tolerances are established for residues of penthiopyrad, N -[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on plant and livestock commodities as indicated below.

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 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:

This is a summary of the Wireline Competition Bureau and the Wireless Telecommunications Bureau's Order in WC Docket Nos. 10-90, 07-135, 05-337, 03-109; GN Docket No. 09-51; CC Docket Nos. 01-92, 96-45; WT Docket No. 10-208; DA 12-147, released on February 3, 2012. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street SW., Washington, DC 20554. Or at the following Internet address: http://transition.fcc.gov/Daily_Releases/Daily_Business/2012/db0203/DA-12-147A1.pdf.

1. In the USF/ICC Transformation Order, 76 FR 76623, December 8, 2011, the Commission delegated to the Wireline Competition Bureau and the Wireless Telecommunications Bureau (Bureaus) the authority to revise and clarify rules as necessary to ensure that the reforms adopted in the Order are properly reflected in the rules. In this Order, the Bureaus act pursuant to this delegated authority to revise and clarify certain rules, and act pursuant to authority delegated to the Bureaus in §§ 0.91, 0.131, 0.201(d), 0.291, and 0.331 of the Commission's rules to clarify certain rules. This Order also modifies certain initial filing deadlines required by § 54.313 of the Commission's rules as necessary to comply with the Paperwork Reduction Act (PRA) requirements, and finds good cause to delete certain rules that are now obsolete.

2. The Bureaus note that petitions for reconsideration of certain aspects of the USF/ICC Transformation Order are pending before the Commission and will be addressed by the Commission in due course. Nothing in this Order is intended to prejudge Commission action with respect to those petitions.

3. Rate Floor. In the USF/ICC Transformation Order, the Commission adopted a rule reducing high-cost support for incumbent carriers receiving high-cost support that charged local rates below a nationwide rate benchmark. The Order “reduce[s], on a dollar-for-dollar basis, HCLS and CAF phase I support,” but excludes Interstate Common Line Support (ICLS) on the basis that it supports “interstate rates, not intrastate end-user rates.” The Order does not specify how the offsets would apply to frozen high-cost support provided pursuant to CAF Phase I, which commingles intrastate and interstate support. For the purposes of calculating certain interstate rates, frozen CAF Phase I support remains attributable to the interstate jurisdiction to the extent that the frozen CAF Phase I support replaced Interstate Access Support. Moreover, the codified rule, § 54.318(d), makes clear that this rate reduction only applies to HCLS and HCMS. In this Order, the Wireline Competition Bureau (Bureau) amends § 54.318(d) to clarify that support reductions associated with the rate floor will offset frozen CAF Phase I support only to the extent that the recipient's frozen CAF Phase I support replaced HCLS and HCMS. The offset does not apply to frozen CAF Phase I support to the extent that it replaced IAS and ICLS.

4. Reporting Requirements for High-Cost Recipients. In the USF/ICC Transformation Order, the Commission adopted or modified several reporting requirements for eligible telecommunications carriers (ETCs) that receive high-cost support. In particular, the Commission adopted a rule, codified in § 54.313, requiring all ETCs receiving high-cost support to file annual reports regarding compliance with the Commission's rules and progress toward its universal service goals. Several of these requirements had previously applied only to federally designated ETCs, under former § 54.209. The Order states that § 54.313 annual reports will be due annually by April 1, beginning on April 1, 2012. As specified in the Order, however, any new reporting requirements are not effective until Federal Register publication of approval by the Office of Management and Budget of the associated information collections under the Paperwork Reduction Act (PRA). The Commission delegated authority to the Bureau to modify initial filing deadlines required by § 54.313 as necessary to comply with the PRA requirements. In this Order, the Bureau clarifies several aspects of those reporting requirements and provides guidance regarding the associated timing of such requirements.

5. First, the Commission stated in the USF/ICC Transformation Order that all ETCs are required to file a new five-year build-out plan by April 1, 2013, to account for the new broadband obligations established in the Order. The Bureau hereby amends § 54.313(a)(1) to clarify this requirement.

6. ETCs previously designated by the Commission are still required to file a progress report on their existing five-year build-out plans currently on file with the Commission but, this year, the progress reports will be due April 1 rather than October 1. On April 1, 2013, those ETCs are required to file with the Commission a new five-year build-out plan that accounts for the new broadband obligations (which will replace the five-year build-out plan currently on file with the Commission) and to send copies to the relevant state commission, relevant authority in a U.S. Territory, or Tribal government, as appropriate. And beginning April 1, 2014, those ETCs are required to file annual progress reports on their new five-year build-out plans.

7. ETCs that have been designated by a state commission should continue to comply with state requirements, if any, regarding service improvement plans. If a state commission previously required an ETC to file a service quality improvement plan or annual updates with the state commission then the ETC should do so, but that ETC is not required to send a copy to the Commission. Similarly, ETCs that are not required by a state commission to file a quality improvement plan with the state commission are not required to file a plan with the Commission this year. However, on April 1, 2013, all state-designated ETCs are required to file with the Commission five-year build-out plans that account for the new broadband obligations adopted in the USF/ICC Transformation Order and to send copies to the relevant state commission, relevant authority in a U.S. Territory, or Tribal government, as appropriate. And beginning April 1, 2014 all state-designated ETCs are required to file annual progress reports on their five-year build-out plans.

8. In the Order, the Commission explained that the five-year build-out plan filed on April 1, 2013 should be consistent with § 54.202(a)(1)(ii). That is, it should describe with specificity proposed improvements or upgrades to the ETC's network throughout its service area, including estimating the area and population that will be served as a result of improvements. This requirement to file a new five-year build-out plan only applies to ETCs that receive high-cost support.

9. Second, § 54.313(a)(2)-(6) requires ETCs annually to file information concerning outages, unfulfilled service requests, and complaints, among other things. We clarify that ETCs that have been designated by the Commission are still required to file that information with respect to their provision of voice service during 2011. But this year, it will be due April 1 rather than October 1. Beginning April 1, 2013, and annually thereafter, those ETCs must file such information separately broken out for both voice and broadband service.

10. We recognize that ETCs that have been designated by a state commission may not have been required to collect and report this information with respect to their provision of voice service during 2011. If state-designated ETCs did not collect this information during 2011, then it would be impossible for them to report it to the Commission in 2012, and they are not required to do so. If state-designated ETCs are subject to a state requirement to report some or all of this information annually to the state, however, then they should file a copy of any relevant information with the Commission in 2012. The Bureau will provide impacted ETCs sufficient time after PRA approval is obtained to file the relevant information. Beginning April 1, 2013, and annually thereafter, state-designated ETCs must file all of the information required by § 54.313(a)(2)-(6), and such information must be separately broken out for both voice and broadband service.

11. Third, the USF/ICC Transformation Order requires that high-cost support recipients provide information demonstrating that they have engaged with Tribal governments in their supported areas, but does not specify a date for doing so. The Order also delegated to the Office of Native Affairs and Policy (ONAP), in coordination with WCB and WTB, the authority to develop processes to guide support recipients in such engagements. Because it will take some time to finalize these processes and for affected ETCs to comply with those requirements, the Bureau clarifies that the initial deadline for reporting information pursuant to this requirement is April 1, 2013 and annually thereafter. That is, ETCs are required to undertake their Tribal engagement obligations in 2012 after ONAP provides engagement process guidance, which will be the substance of the reporting beginning April 1, 2013 and annually thereafter.

12. Fourth, the USF/ICC Transformation Order requires high-cost recipients to annually report ownership information, but does not specify a date for doing so. The Bureau will provide affected ETCs sufficient time after PRA approval is obtained to file the required information. Beginning in 2013, and annually thereafter, the information must be filed by April 1.

13. Fifth, the USF/ICC Transformation Order adopts financial reporting requirements for privately held rate-of-return carriers and specifies that this information must be reported beginning April 1, 2012, subject to PRA approval. The Bureau clarifies that the April 1 reporting date will not be applicable if PRA approval is not received prior to April 1 with sufficient time for respondents to comply. The Bureau will provide sufficient time once PRA approval is obtained for affected ETCs to comply with this requirement.

14. Sixth, the USF/ICC Transformation Order specified that privately held rate-of-return carriers that receive loans from the Rural Utilities Service (RUS) could satisfy their financial reporting obligation by providing electronic copies of their annual RUS reports to the Commission. The Bureau modifies § 54.313(f)(2) to reflect the Commission's intent that such companies may file their RUS reports in lieu of an audited financial statement.

15. Application of the Per-Line Cap to Competitive Eligible Telecommunications Carrier (ETC) Phase Down. In the USF/ICC Transformation Order, the Commission adopted an annual baseline for the phase down of competitive ETC support equal to the lesser of the amount of support the competitive ETC received in 2011 or $3000 per loop (which is $250 per line per month). In this Order, the Bureau clarifies that the $3000 per-loop limit is applicable to competitive ETCs at the incumbent study area level. For example, if a competitive ETC receives an average of $2000 per loop per year serving multiple incumbent study areas, but it receives $3500 per loop per year in one of the study areas, the cap will constrain the competitive ETC's support in that study area. This clarification ensures that, consistent with the Commission's stated rationale, the competitive ETCs' baselines are commensurate with adjustments to the support provided to incumbents serving the same areas.

16. Elimination of Section 54.315 (Disaggregation). Section 54.315 of the Commission's rules permits incumbent local exchange carriers to target the high-cost universal service support they receive to specific areas within their study areas based on the relative costs of serving those areas. This disaggregation of support was intended to ensure that competitive ETCs receive an appropriate per-line support amount for the various areas within the incumbent study area, rather than a single, undifferentiated per-line support amount for the entire study area. Because the Commission eliminated the identical support rule in the USF/ICC Transformation Order and competitive ETCs therefore no longer receive support based on incumbent support amounts, the Commission's disaggregation rule is now obsolete. Because this rule is obsolete, we find good cause to delete it without notice and comment.

17. Elimination of Quarterly Line Counts in Areas Served by a Competitive ETC. In the USF/ICC Transformation Order, the Commission eliminated the identical support rule and adopted a process to phase down competitive ETC support. The Commission also eliminated the requirement that competitive ETCs, except those serving remote areas of Alaska, file quarterly line counts. In this Order, the Bureau amends § 54.903(a)(2) to eliminate requirements for certain quarterly line count filings by incumbent carriers that were necessary only for the purpose of calculating support for competitive ETCs pursuant to the identical support rule. Carriers filing quarterly line counts pursuant to § 54.903(a)(2) solely because of the presence of a competitive ETC will no longer be required to file line counts on a quarterly basis. Carriers may continue to file voluntary updates of line counts. Because the quarterly line filing requirement is obsolete, the Bureau finds good cause to change the Commission's rules without notice and comment.

18. Elimination of Average Schedule Formula for Local Switching Support. In the USF/ICC Transformation Order, the Commission eliminated local switching support (LSS) but did not delete § 54.301, governing LSS, from its rules because several elements continue to be applicable for the purposes of truing up support for prior years. Pursuant to § 54.301(f), the Administrator is required each year to file a proposed formula for calculating LSS for average schedule companies in the next year. Because LSS calculations will not be required on a going forward basis, this requirement is obsolete and the Bureau deletes § 54.301(f). Because this rule is obsolete, we find good cause to delete it without notice and comment.

19. Mobility Fund Phase I Eligibility—Access to Spectrum Requirement. In the USF/ICC Transformation Order, the Commission required that any applicant for a Mobility Fund Phase I auction have access to the spectrum necessary to fulfill any obligations related to support. The Commission further required that such access through a license or leasing arrangement be in effect prior to auction. In order to facilitate auction participation, the Commission concluded that a party could fulfill the spectrum access requirement by acquiring spectrum access that is contingent on obtaining support in the auction. The Commission further found that “failing to ensure spectrum access, on at least a conditional basis, prior to entering a Mobility Fund auction would be inconsistent with the serious undertakings implicit in bidding for support.” This eligibility requirement is codified in § 54.1003(b). This Order amends the rule to clarify that an applicant must have obtained any Commission approvals necessary for the spectrum access prior to submitting an application to participate in competitive bidding.

20. Recovery for Rate-of-Return Carriers. In the USF/ICC Transformation Order, the Commission adopted a transitional recovery mechanism allowing carriers limited recovery of revenues reduced as a result of that Order. The Commission specified a baseline from which a rate-of-return incumbent local exchange carrier's Eligible Recovery would be calculated, and specified that this baseline will decrease by five percent per year. Specifically, the Order correctly stated that a rate-of-return carrier's Eligible Recovery would be determined by reducing its 2011 Rate-of-Return Baseline by a five percent adjustment factor before subtracting its “ICC recovery opportunity” for that year. Under the rules, however, a rate-of-return carrier's Eligible Recovery would be overstated because the five percent adjustment factor would not be applied until after subtracting its ICC recovery opportunity for that year. Applying the adjustment factor after reducing a carrier's baseline by its ICC recovery opportunity would increase the carrier's Eligible Recovery, entitling it to increase charges on end-users and/or to increase its claim to CAF funding, and as a result would reduce the effective adjustment below the amount the Commission specified in the Order. As adopted, §§ 51.917(d)(1)(i)(3) and (4) address the respective components of eligible recovery (Transitional Intrastate Access Service, interstate switched access, and net reciprocal compensation (including both CMRS and non-CMRS reciprocal compensation)) in terms of reductions rather than recovery opportunity. Accordingly, the rule is corrected and revised as set forth in Appendix B to reflect the carrier's intercarrier compensation recovery opportunity for the relevant year and to apply the Rate-of-Return Carrier Baseline Adjustment Factor correctly.

21. Monitoring Compliance with the Recovery Mechanism Rules. In the USF/ICC Transformation Order, the Commission adopted measures to enable it to monitor compliance with the recovery mechanism adopted for incumbent LECs, requiring such carriers to file certain data on an annual basis. The Commission delegated to the Bureau the responsibility to develop and implement the data filing process. To minimize burdens, the USF/ICC Transformation Order noted that the Commission would “ensure that the data filed with USAC [(the Universal Service Administrative Company), for the purpose of justifying a carrier's ability to impose an ARC] is consistent with our request [for Recovery Mechanism compliance monitoring data], so that carriers can use the same format for both filings.” However, because the Commission found that data for monitoring compliance may be filed at the holding company level, whereas the data needed for USAC will be at the study area level, the filings cannot be the same. Thus, we clarify that the data filing requirements for Recovery Mechanism compliance monitoring and for ARC justification will be as consistent as possible, and will be in the same or similar format in order to reduce or eliminate burdens associated with filing wherever possible.

22. Prospective Treatment of VoIP Traffic. In the USF/ICC Transformation Order, the Commission addressed the prospective treatment of VoIP-PSTN traffic by adopting a transitional compensation framework for such traffic. In so doing, the Commission adopted the transitional rules specifying the default compensation for VoIP PSTN-traffic. With regard to “toll” traffic (interstate and intrastate calls), the Commission adopted rules specifying that the default charges for “toll” VoIP-PSTN traffic will be equal to interstate access rates applicable to non-VoIP traffic, both in terms of the rate level and rate structure. We clarify that the prospective VoIP-PSTN framework applies to the interstate rate as well as the interstate structure, including both per-minute (usage sensitive) and flat-rated (dedicated) charges.

23. To implement the VoIP-PSTN framework, the Commission encouraged carriers to negotiate contracts to implement all intercarrier compensation obligations. At the same time, the Commission permitted carriers to include, in their intrastate tariffs, a default means of determining which calls are subject to the VoIP-PSTN framework. In particular, to address concerns that carriers could not identify which calls originate and/or terminate in IP format, the Commission permitted LECs “to specify in its intrastate tariff that the default percentage of traffic subject to the VoIP-PSTN framework is equal to the percentage of VoIP subscribers in the state based on the Local Competition Report, as released periodically.” We clarify that this default percentage is just one means by which a carrier could identify the amount of traffic subject to the VoIP-PSTN framework, and carriers are free to utilize traffic studies, or other reasonable and auditable metrics to determine the percentage of traffic subject to the VoIP-PSTN framework.

24. Operation of VoIP Rules When Interstate Access Rates Exceed Intrastate Access Rates. The Commission adopted a bill-and-keep methodology for all traffic and began the implementation process by providing a measured transition to reduce the terminating rates for most rate elements to bill-and-keep. In so doing, the Commission made clear that, “in cases where a provider's interstate terminating access rates are higher than its intrastate terminating access rates, intrastate rate reductions shall begin to occur at the stage of the transition in which interstate rates come to parity with intrastate rate levels.” Thus, the Commission made clear that it did not intend, under any circumstances, for rates to increase by virtue of its reforms. Indeed, the Commission also capped most rates as of the effective date of the rules, or December 29, 2011, to ensure that no rates increased after the date of the Order. However, in instances where intrastate rates are lower than interstate rates, the Commission did not explain how the prospective VoIP rules would operate—whether the interstate rate would apply in the intrastate tariff or whether the intrastate rate, which is lower, would apply. Parties have notified us that, absent a clarification, intrastate tariffs could have a higher rate for VoIP traffic than other intrastate rates. Such an intrastate rate disparity was not the Commission's intent and could lead to the very arbitrage activities that the USF/ICC Transformation Order intended to eliminate. The Commission held, for example, VoIP-PSTN traffic “will pay most of the same rates as all other traffic in the second year of reform.” Given the mechanics of the transition, this would not be true if VoIP-PSTN traffic were subject to higher intrastate access charges than other traffic, however. Thus, we clarify that, in the limited circumstance of implementing the new intercarrier compensation for VoIP regime adopted in the USF/ICC Transformation Order, when a carrier's intrastate access rate is lower than its corresponding interstate access rate, that carrier may not, in its intrastate tariff, include a rate for toll VoIP-PSTN traffic that is higher than its intrastate access rate.

25. Access Stimulation and Previous Rulings on End Users. In the USF/ICC Transformation Order, the Commission adopted revisions to its interstate switched access charge rules to address access stimulation. Prior to the USF/ICC Transformation Order, the Commission adopted several orders resolving complaints concerning access stimulation under preexisting rules and compliance with the Communications Act. We clarify that the USF/ICC Transformation Order complements these previous decisions, and nothing in the USF/ICC Transformation Order should be construed as overturning or superseding these previous Commission decisions.

26. Access Stimulation and Fee Arrangements. In the USF/ICC Transformation Order, the Commission adopted rules requiring refiling of interstate access tariffs in certain circumstances when a local exchange carrier (LEC) is engaged in access stimulation. In particular, the Commission adopted a rule defining when such tariffs must be refiled. In relevant part, the Commission explained that a LEC must have entered into an access revenue sharing agreement “whether express, implied, written or oral, that, over the course of the agreement, would directly or indirectly result in a net payment to the other party (including affiliates) to the agreement, in which payment by the rate-of-return LEC or competitive LEC is based on the billing or collection of access charges from interexchange carriers or wireless carriers.”

27. We clarify that any arrangement between a LEC and another party, including affiliates, that results in the generation of switched access traffic to the LEC and provides for the net payment of consideration of any kind, whether fixed fee or otherwise, to the other party, including an affiliate, is considered to be “based upon the billing or collection of access charges.”

28. Rural Transport Rule. In the USF/ICC Transformation Order, the Commission adopted an “interim default rule allocating responsibility for transport costs applicable to non-access traffic exchanged between CMRS providers and rural, rate-of-return regulated LECs,” including when a CMRS provider selects an interconnection point outside the LEC's service area. We clarify that, in adopting the interim default rule, the Commission did not intend to affect the existing rules governing points of interconnection (POIs) between CMRS providers and price cap carriers. Indeed, the Commission sought additional comment on issues concerning POI obligations in the Further Notice of Proposed Rulemaking, 76 FR 78384, December 16, 2011.

29. Although this document clarifies several existing information collection requirements, it does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it 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, see 44 U.S.C. 3506(c)(4).

30. Final Regulatory Flexibility Certification. The Regulatory Flexibility Act of 1980, as amended (RFA) requires that a regulatory flexibility analysis be prepared for rulemaking proceedings, unless the agency certifies that “the rule will not have a significant economic impact on a substantial number of small entities.” The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

31. This Order clarifies, but does not otherwise modify, the USF/ICC Transformation Order. These clarifications do not create any burdens, benefits, or requirements that were not addressed by the Final Regulatory Flexibility Analysis attached to USF/ICC Transformation Order. Therefore, we certify that the requirements of this Order will not have a significant economic impact on a substantial number of small entities. The Commission will send a copy of the Order including a copy of this final certification, in a report to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, see 5 U.S.C. 801(a)(1)(A). In addition, the Order and this certification will be sent to the Chief Counsel for Advocacy of the Small Business Administration, and will be published in the Federal Register. See 5 U.S.C. 605(b).

32. The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

33. Accordingly, it is ordered, that pursuant to the authority contained in sections 1, 2, 4(i), 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, and 403 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 1302, and pursuant to §§ 0.91, 0.131, 0.201(d), 0.291, 0.331, 1.3, and 1.427 of the Commission's rules, 47 CFR 0.91, 0.131, 0.201(d), 0.291, 0.331, 1.3, 1.427 and pursuant to the delegations of authority in paragraphs 581 and 1404 of FCC 11-161 (rel. Nov. 18, 2011), that this Order is adopted, effective April 9, 2012, except for those rules and requirements involving Paperwork Reduction Act burdens, which shall become effective immediately upon announcement in the Federal Register of OMB approval.

34. It is further ordered, that Parts 51 and 54 of the Commission's rules, 47 CFR Parts 51, 54, are amended as set forth below, and such rule amendments shall be effective April 9, 2012, except to the extent they contain information collections subject to PRA review. The rules that contain information collections subject to PRA review will become effective upon announcement in the Federal Register of OMB approval and an effective date of the rule(s).

35. It is further ordered, that the Commission shall send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

36. It is further ordered, that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 51 and 54 to read as follows:

Beginning in 1995, fishing for Pacific halibut and sablefish with fixed gear in the IFQ regulatory areas defined in 50 CFR 679.2 has been managed under the IFQ Program. The IFQ Program is a regulatory regime designed to promote the conservation and management of these fisheries and to further the objectives of the Magnuson-Stevens Fishery Conservation and Management Act and the Northern Pacific Halibut Act. Persons holding quota share receive an annual allocation of IFQ. Persons receiving an annual allocation of IFQ are authorized to harvest IFQ species within specified limitations. Further information on the implementation of the IFQ Program, and the rationale supporting it, are contained in the preamble to the final rule implementing the IFQ Program published in the Federal Register, November 9, 1993 (58 FR 59375) and subsequent amendments.

This announcement is consistent with § 679.23(g)(1), which requires that the directed fishing season for sablefish managed under the IFQ Program be specified by the Administrator, Alaska Region, and announced by publication in the Federal Register . This method of season announcement was selected to facilitate coordination between the sablefish season, chosen by the Administrator, Alaska Region, and the halibut season, adopted by the International Pacific Halibut Commission (IPHC). The directed fishing season for sablefish with fixed gear managed under the IFQ Program will open 1200 hrs, A.l.t., March 17, 2012, and will close 1200 hrs, A.l.t., November 7, 2012. This period runs concurrently with the IFQ season for Pacific halibut announced by the IPHC. The IFQ halibut season will be specified by a separate publication in the Federal Register of annual management measures pursuant to 50 CFR 300.62.

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of the sablefish fishery thereby increasing bycatch and regulatory discards between the sablefish fishery and the halibut fishery, and preventing the accomplishment of the management objective for simultaneous opening of these two fisheries. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 30, 2012.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.23 and is exempt from review under Executive Order 12866.

On February 3, 2012, NMFS published a final rule in the Federal Register (77 FR 5389) to implement the Chinook Salmon Economic Data Report Program, which will evaluate the effectiveness of Chinook salmon bycatch management measures for the Bering Sea pollock fishery that were implemented under Amendment 91 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area. This final rule added a regulatory provision at 50 CFR 679.5(e)(6)(i)(A)( 12 ), which describes deliveries from catcher vessels directed fishing for pollock in the Bering Sea in which the operator of the catcher vessel moved fishing location primarily to avoid Chinook salmon bycatch. However, a final rule implementing Amendment 83 to the Fishery Management Plan for Groundfish of the Gulf of Alaska previously had added a § 679.5(e)(6)(i)(A)( 12 ), which describes the receipt of groundfish deliveries in the marine municipal boundaries of a Community Quota Entity community. (76 FR 74640; December 1, 2011). Thus, there are two different regulatory paragraphs numbered § 679.5(e)(6)(i)(A)(12).

If this error is not corrected, the regulatory text at § 679.5(e)(6)(i)(A)(12) implementing Amendment 83 will be removed and replaced by the regulatory text implementing the Chinook Salmon Economic Data Report Program. Therefore, this correction is necessary to fully implement Amendment 83. This action corrects the final rule implementing the Chinook Salmon Economic Data Report Program by renumbering § 679.5(e)(6)(i)(A)(12) as § 679.5(e)(6)(i)(A)(13).

The Assistant Administrator for Fisheries, NOAA (AA), finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be unnecessary and contrary to the public interest. This error must be corrected immediately to fully implement Amendment 83. Left uncorrected, the regulatory text at § 679.5(e)(6)(i)(A)(12) implementing Amendment 83 will be removed and replaced by the text implementing the Chinook Salmon Economic Data Report program The correction will ensure that regulations in this section include all of the regulatory text intended by the two programs.

If the effective date for this correction is delayed to solicit prior public comment, this technical error will not be corrected by the effective date of this final rule, thereby undermining the conservation and management objectives of the fishery management plans. Moreover, the public has already had opportunity to comment on both provisions included in the two final rules. Thus, further public comment is unnecessary.

The AA further finds, pursuant to 5 U.S.C.553(d)(3), good cause to waive the thirty (30) day delayed effectiveness period for the reasons stated above.

NMFS is correcting this error and is not making substantive changes to the rule document published on February 3, 2012 (77 FR 5389).

In FR Doc. 2012-2361, appearing on page 5389 in the Federal Register of Friday, February 3, 2012, the following corrections are made:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The A season allowance of the 2012 Pacific cod total allowable catch (TAC) apportioned to vessels using jig gear in the Central Regulatory Area of the GOA is 256 metric tons (mt), as established by the final 2011 and 2012 harvest specifications for groundfish of the GOA (76 FR 11111, March 1, 2011), revision to the final 2012 harvest specifications for Pacific cod (76 FR 81860, December 29, 2011), and inseason adjustment to the final 2012 harvest specifications for Pacific cod (77 FR 438, January 5, 2012).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2012 Pacific cod TAC apportioned to vessels using jig gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 246 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using jig gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by vessels using jig gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 5, 2012.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.