Compliance Regulations and Guidance Affecting your Industry

FAA and DOT propose to adopt a new airworthiness directive (AD) for certain Model 737–200, –300, –400, and –500 series airplanes. This proposed AD would require repetitive inspections for cracking of certain fuselage frames and stub beams, and corrective actions if necessary. This proposed AD also provides for an optional repair, which would terminate the repetitive inspections. For airplanes on which a certain repair is done, this proposed AD would also require repetitive inspections for cracking of certain fuselage frames and stub beams, and corrective actions if necessary. This proposed AD results from reports of the detection of fatigue cracks at certain frame sections, in addition to stub beam cracking, caused by high flight cycle stresses from both pressurization and maneuver loads. FAA and DOT are proposing this AD to detect and correct fatigue cracking of certain fuselage frames and stub beams and possible severed frames, which could result in reduced structural integrity of the frames. This reduced structural integrity can increase loading in the fuselage skin, which will accelerate skin crack growth and could result in rapid decompression of the fuselage.

DATES: FAA and DOT must receive comments on this proposed AD by June 21, 2010.

 

EPA and NHTSA are issuing this joint Final Rule to establish a National Program consisting of new standards for light-duty vehicles that will reduce greenhouse gas emissions and improve fuel economy. This joint Final Rule is consistent with the National Fuel Efficiency Policy announced by President Obama on May 19, 2009, responding to the country’s critical need to address global climate change and to reduce oil consumption. EPA is finalizing greenhouse gas emissions standards under the Clean Air Act, and NHTSA is finalizing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, covering model years 2012 through 2016, and represent a harmonized and consistent National Program. Under the National Program, automobile manufacturers will be able to build a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices. NHTSA’s final rule also constitutes the agency’s Record of Decision for purposes of its National Environmental Policy Act (NEPA) analysis.

DATES: This final rule is effective on July 6, 2010
 

The Securities and Exchange Commission (“Commission”) is proposing new Rule 613 under Section 11A(a)(3)(B) of the Securities Exchange Act of 1934 (“Exchange Act”) that would require national securities exchanges and national securities associations (“self-regulatory organizations” or “SROs”) to act jointly in developing a national market system (“NMS”) plan to develop, implement, and maintain a consolidated order tracking system, or consolidated audit trail, with respect to the trading of NMS securities.

The Commission preliminarily believes that with today’s electronic, interconnected markets, there is a heightened need for regulators to have efficient access to a more robust and effective cross-market order and execution tracking system. Currently, many of the national securities exchanges and the Financial Industry Regulatory Authority, Inc. (“FINRA”) have audit trail rules and systems to track information relating to orders received and executed, or otherwise handled, in their respective markets. While the information gathered from these audit trail systems aids the SRO and Commission staff in their regulatory responsibility to surveil for compliance with SRO rules and the federal securities laws and regulations, the Commission preliminarily believes that existing audit trails are limited in their scope and effectiveness in varying ways. In addition, while the SRO and Commission staff also currently receive information about orders or trades through the electronic bluesheet (“EBS”) system, Rule 17a-25 under the Exchange Act,1 or from equity cleared reports, the information is limited, to varying degrees, in detail and scope.

A consolidated audit trail would significantly aid in SRO efforts to detect and deter fraudulent and manipulative acts and practices in the marketplace, and generally to regulate their markets and members. In addition, such an audit trail would benefit the Commission in its market analysis efforts, such as investigating and preparing market reconstructions and understanding causes of unusual market activity. Further, timely pursuit of potential violations can be important in seeking to freeze and recover any profits received from illegal activity.

DATES: Comments should be received on or before August 9, 2010.

 

This guidance document is intended to provide information related to FDA's enforcement policy concerning Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by Section 204 of the Family Smoking Prevention and Tobacco Control Act. Section 204 of the Tobacco Control Act amended Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the “Smokeless Tobacco Act,” 15 U.S.C. 4402), to prescribe new requirements for health warning labels that must appear on smokeless tobacco product packages and advertising, and to require that rotational warning plans for packaging and advertising for smokeless tobacco products be submitted to FDA, rather than to the Federal Trade Commission (FTC).

This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics. This guidance applies to clinical investigations conducted under 21 CFR Part 312 (Investigational New Drug Applications or IND regulations). It describes how to complete the Statement of Investigator form (Form FDA 1572).

This draft guidance is intended to assist manufacturers, distributors, retailers, and others who sell cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents and to explain what you should do in order to comply with the regulations.

This final rule amends FAA regulations by adding equipage requirements and performance standards for Automatic Dependent Surveillance—Broadcast (ADS–B) Out avionics on aircraft operating in Classes A, B, and C airspace, as well as certain other specified classes of airspace within the U.S. National Airspace System (NAS). ADS–B Out broadcasts information about an aircraft through an onboard transmitter to a ground receiver. Use of ADS–B Out will move air traffic control from a radar-based system to a satellite-derived aircraft location system. This action facilitates the use of ADS–B for aircraft surveillance by FAA and Department of Defense (DOD) air traffic controllers to safely and efficiently accommodate aircraft operations and the expected increase in demand for air transportation. This rule also provides aircraft operators with a platform for additional flight applications and services.

DATES: This final rule is effective on August 11, 2010.

 

ThE Order establishes the policy, process and procedures for control of sensitive use control information in nuclear weapon data (NWD) categories Sigma 14 and Sigma 15 to ensure that dissemination of the information must be restricted to individuals with valid need to know.

Issued Date:  May 14, 2010

Effective Date: May 14, 2010

 

The order establishes safety requirements for the proper packaging and transportation of DOE, including NNSA, offsite shipments and onsite transfers of radioactive and other hazardous materials and for modal transportation.

Issued Date: May 14, 2010

Effective Date: May 14, 2010
 

In this Final Rule, the Commission revises the contract reporting requirements for those natural gas pipelines that fall under the Commission’s jurisdiction pursuant to section 311 of the Natural Gas Policy Act or section 1(c) of the Natural Gas Act. The Final Rule revises § 284.126(b) and replaces Form No. 549 – Intrastate Pipeline Annual Transportation Report with the new Form No. 549D – Quarterly Transportation and Storage Report for Intrastate Natural Gas and Hinshaw Pipelines. The Final Rule makes changes so as to (1) increase the reporting frequency from annual to quarterly, (2) include certain additional types of information and cover storage transactions as well as transportation transactions, (3) establish a procedure for the Form No. 549D reports to be filed in a uniform electronic format and posted on the Commission’s web site, (4) and hold that those reports must be public and may not be filed with information redacted as privileged. The Commission is also modifying its policy concerning periodic reviews of the rates charged by section 311 and Hinshaw pipelines to extend the cycle for such reviews from 3 years to 5 years.

Effective Date: This rule will become effective April 1, 2011.

 

PHMSA is amending the Federal pipeline safety regulations to address human factors and other aspects of control room management for pipelines where controllers use supervisory control and data acquisition (SCADA) systems. Under the final rule, affected pipeline operators must define the roles and responsibilities of controllers and provide controllers with the necessary information, training, and processes to fulfill these responsibilities. Operators must also implement methods to prevent controller fatigue. The final rule further requires operators to manage SCADA alarms, assure control room considerations are taken into account when changing pipeline equipment or configurations, and review reportable incidents or accidents to determine whether control room actions contributed to the event.

Hazardous liquid and gas pipelines are often monitored in a control room by controllers using computer-based equipment, such as a SCADA system, that records and displays operational information about the pipeline system, such as pressures, flow rates, and valve positions. Some SCADA systems are used by controllers to operate pipeline equipment, while, in other cases, controllers may dispatch other personnel to operate equipment in the field. These monitoring and control actions, whether via SCADA system commands or direction to field personnel, are a principal means of managing pipeline operation.

This rule improves opportunities to reduce risk through more effective control of pipelines. It further requires the statutorily mandated human factors management. These regulations will enhance pipeline safety by coupling strengthened control room management with improved controller training and fatigue management.

DATE: Effective Date: The effective date of this final rule is February 1, 2010.

 

This final rule addresses the safety regulation responsibility for producer-operated natural gas and hazardous liquid pipelines that cross into State waters without first connecting to a transporting operator’s facility on the Outer Continental Shelf (OCS). This rule specifies the procedures by which producer operators can petition for approval to operate under safety regulations governing pipeline design, construction, operation, and maintenance issued by either the Research and Special Programs Administration (RSPA) or the Department of the Interior (DOI), Minerals Management Service (MMS).

DATES: This rule is effective September 4, 2003.

 

This regulation prescribes procedures used by the Pipeline and Hazardous Materials Safety Administration in carrying out duties regarding pipeline safety under 49 U.S.C. 60101 et seq. (the pipeline safety laws) and 49 U.S.C. 5101 et seq. (the hazardous material transportation laws).

EPA is taking direct final action to approve revisions to the Placer County Air Pollution Control District (PCAPCD), Sacramento Metropolitan Air Quality Management District (SMAQMD), San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD), and South Coast Air Quality Management District (SCAQMD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from petroleum facilities, chemical plants, and facilities which use organic solvents. We are approving local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).

DATES: This rule is effective on July 6, 2010 without further notice.

 

This part prescribes procedures used by the Pipeline and Hazardous Materials Safety Administration in carrying out duties regarding pipeline safety under 49 U.S.C. 60101 et seq. (the pipeline safety laws) and 49 U.S.C. 5101 et seq. (the hazardous material transportation laws).

This action will establish Class E airspace at Hailey, ID, to accommodate aircraft using the Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Friedman Memorial Airport. This will improve the safety of Instrument Flight Rules (IFR) operations at the airport.

Effective Date: 0901 UTC, June 3, 2010.

 

This action amends Class E airspace for Mapleton, IA, adding additional controlled airspace to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAPs) at James G. Whiting Memorial Field Airport, Mapleton, IA. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date 0901 UTC, July 29, 2010.

 

We are superseding an existing airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. We are issuing this AD to require actions to correct the unsafe condition on these products.

DATES: This AD becomes effective June 8, 2010.

 

The FAA is superseding an existing airworthiness directive (AD) for CFM International, S.A. CFM56–5B series turbofan engines. That AD requires reviewing exhaust gas temperature (EGT) monitoring records to determine EGT margin deterioration, and for airplanes where both engines have greater than 80 °centigrade (C) of EGT margin deterioration, borescopeinspecting the high-pressure compressor (HPC) of both engines. That AD also requires removing from service any engine that does not pass the borescope inspection and, if both engines pass, replacing one of the engines with an engine that has 80 °C or less of EGT margin deterioration. That AD also requires continuous monitoring of EGT margin deterioration on engines in service to prevent two engines on an airplane from having greater than 80 °C of EGT margin deterioration. This AD:

• Reduces the number of engine models affected;
• Continues to monitor EGT margin deterioration;
• Lowers the EGT margin threshold from 80 °C to 75 °C;
• Removes FADEC software version 5.B.Q and earlier versions from the engine as mandatory terminating action to the continuous EGT margin deterioration monitoring, for certain engine models;
• Removes the requirement to borescope inspect; and
• Removes the requirement to replace one of the engines with an engine that has 80 °C or less deterioration of EGT margin as a corrective action.

This AD results from a reduction of the affected engine models listed in AD 2009–01–01 from 25 to 19, a reduction in the engine EGT margin deterioration threshold from 80 °C to 75 °C, the introduction of terminating action to the continuous EGT monitoring for certain engines, and a change to the removal plan for the remaining engines if the EGT margin deterioration is greater than 75 °C. We are issuing this AD to prevent HPC stalls, which could prevent continued safe flight or landing.

DATES: This AD becomes effective June 8, 2010. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of June 8, 2010.