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News : Regulatory Affairs

15 July 2015

EN/ISO 11137 parts 1,2 and 3 – Microbiological and Dosimetric issues.

There is a very important initiative being undertaken by EMPIR (European Metrology Programme for Innovation and Research).   Refer to the attached document.   This initiative has significant consequences for the industry in terms of how product is currently processed. “Recent revisions of the medical device radiation sterilization standards (EN/ISO 11137-1,2&3 have highlighted the lack of a[…]

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8 June 2015

Senator Gardner introduces PORTS Act to protect American economy

Washington, DC – Senator Cory Gardner (R-CO) announced on Friday 5th June that he had introduced the Protecting Orderly and Responsible Transit of Shipments (PORTS) Act in the United States Senate to safeguard the American economy from the threat of labor shutdowns and slowdowns at seaports. The Act is designed to ensure that labour disputes[…]

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26 February 2015

Australia New Zealand Food Standards – approvals

On 20th February 2015, Australia New Zealand Food Standards has approved the irradiation between 150 Gy and 1 kGy of apple, apricot, cherry, nectarine, peach, plum, honeydew, rockmelon, scaloppini, strawberry, table grape and zucchini (courgette). The purpose should be pest disinfestation for a phytosanitary objective. This brings to 24 the number of commodities for which phytosanitary irradiation[…]

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1 October 2014

US NRC Security – Planned Changes.

The US Nuclear Regulatory Commission (NRC) is amending the regulations governing security related information for large irradiators, producers, distributors and transporters. Details are outlined in the attached extract from the Federal Register 10 CFR Parts 30, 37, 73 and 150 (NRC 2012 0140).   Federal Register Vol 70 Number 189

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10 September 2014

Proposed US Regulatory Action

In the USA a Bill making appropriations for: energy and water development and related agencies for the fiscal year ending September 30, 2015 and for other purposes includes potentially important targets that could impact on operators of production irradiators. We would draw your attention to pages 68-74 inclusive of the attached Bill. These pages include[…]

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4 September 2014

Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards

IAEA Safety Standards Series No. GSR Part 3 This is a revised version of the International Basic Safety Standards. Co-sponsored by seven other international organizations (EC/Euratom, FAO, ILO, OECD/NEA, PAHO, UNEP and WHO) the Standard details the requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety[…]

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12 August 2014

Regulations for the Safe Transport of Radioactive Material

Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (2012 Edition) IAEA Safety Standards Series No. SSG-26 This Safety Guide provides recommendations and guidance on achieving and demonstrating compliance with IAEA Safety Standards Series No. SSR-6, Regulations for the Safe Transport of Radioactive Material (2012 Edition), which establishes the requirements to[…]

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23 April 2014

Crustaceans – FDA amends regulations to provide for safe use of ionizing radiation

SUMMARY: The Food and Drug Administration (‘‘FDA’’ or ‘‘we’’) is amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens in crustaceans at a maximum absorbed dose of 6.0 kiloGray (kGy). This action is in response to a petition filed by the National Fisheries Institute. DATES:[…]

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