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News : Regulatory Affairs

27 September 2007

Finding of No Significant Impact, Pa’ina Irradiator Final Environmental Assessment

The US Nuclear Regulatory Commission (NRC) published the “Notice of Availability of Final Environmental Assessment and Finding of No Significant Impact for Proposed Pa’ina Hawaii, LLC Irradiator in Honolulu, HI”, on Friday August 17, 2007 in the Federal Register/ Vol. 72. No. 159 pages 46249- 46251. Typically the licensing of panoramic or underwater irradiators does […]

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9 August 2007

A New Era for European Standardization

The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) recently took action to strengthen the common values and principles of the European standardization system at their third annual meeting in Lemesos, Cyprus. The Cyprus decision seeks to create a more open, flexible, and dynamic system to anticipate and respond to […]

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28 March 2007

Why the Changes and Additions to ISO 11137

Readers of iiA eNewsletter will be aware of the publication in 2006 of the two normative ‘radiation’ standards, (EN) ISO 11137-1 Requirements for development, validation and routine control of a sterilization process for medical devices and (EN) ISO 11137-2 Establishing the sterilization dose; these, with time, will replace the original standards, EN 552:1994 and ISO […]

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28 March 2007

Irradiation of Wood Packaging Material- ISPM 15 under revision

Currently there is no internationally approved international standard for phytosanitary measure (ISPM) for the treatment of wood packaging (e.g. pallets, crates, boxes) that allows for the use of irradiation. In 2007, the International Plant Protection Convention Secretariat, Food and Agriculture Organization (FAO) of the United Nations will be calling for submissions of treatments of wood […]

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22 February 2007

The Position of EN ISO 11137-2 in Europe

Following the joint CEN and ISO revision of EN 552:1994 and ISO 11137:1995 (with ISO lead) and the requisite CEN and ISO approvals of the resulting documents, ISO published the first edition of ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose on 15 April 2006. As is […]

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26 January 2007

NRC Pai’ina Irradiator Public Meeting

The Nuclear Regulatory Commission (NRC) will hold a public meeting in Honolulu on Feb. 1 to seek public comment on a draft environmental assessment for a proposed irradiator to be built and operated adjacent to the Honolulu International Airport. Based on the draft assessment, the NRC concludes that there would be no significant environmental impact […]

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1 October 2006

IAEA Safe Transport of Radioactive Material

The IAEA has been publishing Regulations for the Safe Transport of Radioactive Material since 1961. Meeting its statutory obligation to foster the exchange and training of scientists and experts in the field of peaceful uses of atomic energy, the IAEA has developed a standardized approach to transport safety training. This training manual is an anchor […]

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1 May 2006

NAS Radiation Source Use and Replacement

The USA National Academy of Sciences (NAS) is a prestigious society engaged in scientific and engineering research. Founded March 3, 1863 by President Abraham Lincoln, government leaders frequently turn to NAS for advice on complex and critical science and technical issues that permeate policy decisions. One of their current projects is to report on radiation […]

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1 May 2006

Update on development of ISO/TC34 Food Irradiation Standard

Convenor Romina Garay cancelled the first meeting of ISO/TC 34/ WG 10 scheduled for May 10 to 12th in Buenos Aires, Argentina because only 2 people registered. Unfortunately the need for this work has not been justified, since many believe the existing Codex documents and ISO/ASTM standards are sufficient and of much higher quality. However […]

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1 May 2006

NRC Response to the GOA

The US NRC has issued a very good 4-page letter to the Chairman, Permanent Subcommittee on Investigations, Committee on Homeland Security and Government Affairs with respect to the security and control of radioactive sources. This was in response to the Government Accountability Office’s (GOA) actions in transporting (smuggling) a very small amount of radioactive material […]

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