Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites.

DATES: This rule is effective May 12, 2010.

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an oral suspension containing orbifloxacin for the treatment of various bacterial infections in dogs and cats.

DATES: This rule is effective May 12, 2010.

 

The order establishes requirements for verifying readiness for startup of new Hazard Category 1, 2, and 3 nuclear facilities, activities, and operations, and for restart of existing Hazard Category 1, 2, and 3 nuclear facilities, activities, and operations that have been shut down. Cancels DOE O 425.1C

Issued Date: April 16, 2010

Effective Date: April 16, 2010

The order establishes facility and programmatic safety requirements for nuclear and explosives safety design criteria, fire protection, criticality safety, natural phenomena hazards (NPH) mitigation, and the System Engineer Program.

Issued Date: April 19, 2010

Effective Date: April 19, 2010

 

The order establishes selection, training, qualification, and certification requirements for contractor personnel who can impact the safety basis through their involvement in the operation, maintenance, and technical support of Hazard Category 1, 2, and 3 nuclear facilities. Cancels DOE O 5480.20A.

Issued Date: April 21, 2010

Effective Date: April 19, 2010

The order defines the safety management program required by 10 CFR 830.204(b)(5) for maintenance and the reliable performance of structures, systems and components that are part of the safety basis required by 10 CFR 830.202 at hazard category 1, 2 and 3 DOE nuclear facilities. Cancels DOE O 433.1A.

Issued Date: April 21, 2010

Effective Date:  April 21, 2010

This document contains a technical correction to the final rule regarding the certification, compliance and enforcement regulations that was published on January 5, 2010. In that final rule, the U.S. Department of Energy (DOE) adopted regulations to implement reporting requirements for energy conservation standards and energy use, and to address other matters, including compliance certification, prohibited actions, and enforcement procedures for specific consumer products and commercial and industrial equipment. Due to drafting errors, language added to the rule in one amendment was deleted from the rule by another amendment, and certain erroneous internal cross references were made. This correction addresses these errors.

DATES: This technical correction is effective February 4, 2010.

 

The FAA is replacing Special Federal Aviation Regulation 100–1(SFAR 100–1), with SFAR 100–2 that continues to allow Flight Standards District Offices (FSDOs) to accept expired flight instructor certificates and inspection authorizations for renewals from U.S. military and civilian personnel (U.S. personnel) who are assigned outside the United States in support of U.S. Armed Forces operations. SFAR 100–2 also continues to allow FSDOs to accept expired airman written test reports for certain practical tests from U.S. personnel who are assigned outside the United States in support of U.S. Armed Forces operations. This action is necessary to avoid penalizing U.S. personnel who are unable to meet the regulatory time limits of their flight instructor certificate, inspection authorization, or airman written test report because they are serving outside the United States in support of U.S. Armed Forces operations. The effect of this action is to give U.S. personnel who are assigned outside the United States in support of U.S. Armed Forces operations extra time to meet certain eligibility requirements in the current rules.

DATES: This final rule is effective June 20, 2010.

 

The FAA is adopting a new airworthiness directive (AD) for GE CJ610 series turbojet engines and CF700 turbofan engines with AFT Technologies combustion liners, part number (P/N) AFT–5016T30G02. This AD requires removing from service, AFT Technologies combustion liners, P/N AFT–5016T30G02. This AD results from a report of an AFT Technologies combustion liner that released a large section of the inner combustion liner and reports of six combustion liners with premature cracks. We are issuing this AD to prevent premature cracks in the combustion liner, which could release pieces of the inner combustion liner. A release of pieces of the inner combustion liner could cause an uncontained failure of the engine turbine and damage to the airplane.

DATES: This AD becomes effective May 28, 2010.

 

This is the third edition of the Compliance Guideline for Controlling Salmonella and Campylobacter in Poultry. This update includes additional pre-harvest recommendations for controlling Salmonella and Campylobacter. Future editions will continue to reflect feedback received from all stakeholders. This Compliance Guideline follows the procedures for guidance documents in the Office of Management and Budget’s (OMB) “Final Bulletin for Agency Good Guidance Practices” (GGP).

This Compliance Guideline represents current FSIS thinking on this topic and should be considered usable as of this issuance. This guideline for poultry articulates how industry can meet FSIS expectations regarding control of food safety hazards. The guidelines summarize known control points for Salmonella and Campylobacter in the pre- and post-harvest production process, and include summaries of scientific studies that can be used to support specific control parameters. The guidelines will be updated as needed to reflect the most current information available to FSIS and stakeholders.

This is the second edition of the Compliance Guideline for poultry slaughter. This update includes recommendations for controlling both Salmonella and Campylobacter. Future editions will continue to reflect feedback received from all stakeholders. In order to make this guideline as useful as possible, FSIS encourages all persons interested to submit their comments and concerns regarding any aspect of this document including but not limited to: content, readability, applicability, and accessibility.

This is the first edition of the Compliance Guideline regarding Salmonella control in poultry slaughter. This compliance guideline describes concerns and validated controls for each step in the broiler slaughter process. In order to make this guideline as useful as possible, FSIS encourages all persons interested to submit their comments and concerns regarding any aspect of this document including but not limited to: content, readability, applicability, and accessibility.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Device User Fee Cover Sheet— Form FDA 3601’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

DATES: This rule is effective May 17, 2010.

 

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 7, 2010.

 

This action confirms the effective date of a direct final rule published in the Federal Register December 7, 2009 that establishes Class E airspace at Fort A.P. Hill, VA.

Effective Date: 0901 UTC, April 21, 2010.

 

This action modifies Jet Routes J-37 and J-55 by terminating the routes at navigation aid facilities prior to the U.S./Canadian border. The FAA is taking this action to support the En Route Automation Modernization (ERAM) program.

Effective Date: 0901 UTC, June 3, 2010

EPA has made a final decision to continue applying the Agency’s existing interpretation of a regulation that determines the scope of pollutants subject to the Federal Prevention of Significant Deterioration (PSD) program under the Clean Air Act (CAA or Act). In a December 18, 2008 memorandum, EPA established an interpretation clarifying the scope of the phrase ‘‘subject to regulation’’ found within the definition of the term ‘‘regulated NSR pollutant.’’ After considering comments on alternate interpretations of this term, EPA has decided to continue to interpret it to include each pollutant subject to either a provision in the CAA or regulation adopted by EPA under the CAA that requires actual control of emissions of that pollutant. Thus, this action explains that EPA will continue following the interpretation in the December 18, 2008 memorandum with one exception. EPA is refining its interpretation to establish that the PSD permitting requirements will not apply to a newly regulated pollutant until a regulatory requirement to control emissions of that pollutant ‘‘takes effect.’’ In addition, this notice addresses several questions regarding the applicability of the PSD and Title V permitting programs to greenhouse gases (GHGs) upon the anticipated promulgation of EPA regulations establishing limitations on emissions of GHGs from vehicles under Title II of the CAA. Collectively, these conclusions result in an EPA determination that PSD and Title V permitting requirements will not apply to GHGs until at least January 2, 2011.

DATES: This final action is applicable as of March 29, 2010.

 

The Environmental Protection Agency (EPA or the Agency) is taking Direct Final action on a number of technical changes that correct or clarify several parts of the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations that relate to hazardous waste identification, manifesting, the hazardous waste generator requirements, standards for owners and operators of hazardous waste treatment, storage and disposal facilities, standards for the management of specific types of hazardous waste and specific types of hazardous waste management facilities, the land disposal restrictions program, and the hazardous waste permit program. These changes correct existing errors in the hazardous waste regulations that have occurred over time in numerous final rules published in the Federal Register, such as typographical errors, incorrect or outdated citations, and omissions. Someof the corrections are necessary to make conforming changes to all appropriate parts of the RCRA hazardous waste regulations for new rules that have since been promulgated. In addition, these changes clarify existing parts of the hazardous waste regulatory program and update references to Department of Transportation (DOT) regulations that have changed since the publication of various RCRA hazardous waste final rules.

DATES: This Direct Final Rule is effective on June 16, 2010 without further notice unless EPA receives adverse comments by May 3, 2010. If adverse comment is received, EPA will publish a timely withdrawal of the Direct Final rule in the Federal Register informing the public that the rule will not take effect.

 

This action clarifies regulatory text of the ‘‘Revision of Source Category List for Standards Under Section 112(k) of the Clean Air Act; National Emission Standards for Hazardous Air Pollutants: Paints and Allied Products Manufacturing Area Source Standards’’ which was issued as a final rule on December 3, 2009. These technical corrections will not change the level of health protection the final rule provides or the standards and other requirements established by the rule.

Effective Date: March 5, 2010