International notification

Owners/operators and manufacturers may adopt internal notification practices to assist in the collection and distribution of prior-use information. For example, an owner/operator or manufacturer may utilize email, memorandums, or technical alert systems to flag problems relating to use of a specific device in either a BPCS or SIS application. This alerts personnel assigned responsibility for the SIS to problems relating to the use of specific devices in critical applications. 

Severity Incident Threshold OSHA 300 Report Incident Investigation Report (HR) Internal Notification Report to OSHA within 8 hours... 

The language of the supplier notification requirements covers mixtures or trade name products that are sold or otherwise distributed. The "otherwise distributes" language applies to intra-company transfers. However, if the company has developed an internal communications procedure that alerts their other facilities to the presence and content of covered toxic chemicals in their products, then EPA would accept this. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

ICPs should ensure that hospitals have current telephone numbers for notification of both internal (ICPs, epidemiologists, infectious diseases specialists, administrators, and public affairs officials) and external (state and local health departments, Federal Bureau of Investigation field office, and CDC Emergency Response office) contacts and that they are distributed to the appropriate personnel.9 ICPs should work with clinical microbiology laboratories, on- or off-site, that receive specimens for testing from their facility to ensure that cultures from suspicious cases are evaluated appropriately. 

The Directive contains these other requirements concerning toxicity information and test data (1) Notifications must include descriptions of the studies conducted and methods used (Article 6(1), and Annex VII, Introductory Statements) (2) The tests must be performed according to the methods specified in Annex V (Article 3(1)), and must be "recognized and recommended by the competent international bodies where such recommendations exist" (Annex VII, Introductory Statements) (3) The persons who carry out the tests must comply with the principles of current good laboratory practice (Annex VII, Introductory Statements) and (4) The notifications must include the composition of samples used in testing, and the name of the persons responsible for carrying out the studies (Annex VII, Introductory Statements). 

During most emergencies, it will be necessary to quickly notify a variety of parties both internal and external to the chemical plant. Using the Chain-of-Command Chart and all appropriate personnel from the lists below, indicate who activates the plan, the order in which notification occurs, and the members of the emergency response team. All contact information should be available for routine updating and readily available. The following lists are not intended to be all inclusive—they should be adapted to your specific needs. 

Major manufacturing and trading countries now routinely supply pre-export notifications for all shipments of precursors of amphetamine-type stimulants in international trade. The Board has noted that, because of the effective controls and monitoring mechanisms that now exist for the licit trade in the raw materials, traffickers in certain regions are increasingly turning to pharmaceutical preparations as a source of the required precursors, particularly ephedrine and pseudoephedrine. 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

In its 2007 report on the implementation of article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988, the International Narcotics Control Board informs Governments of the notification that the Board has sent to the Secretary-General, to formally initiate the procedures to transfer phenylacetic acid from Table II to Table I of the Convention. The Board believes that the transfer is necessary because existing controls over phenylacetic acid are insufficient to prevent the diversion of the substance from continuing. 

Polyak, C. S., Elbert, Y, Pavlin, J. A., Kelley, P. W. (2002, March). The Electronic Surveillance System for the Early Notification of Community-based Epidemics (ESSENCE) GIS modeling in an early detection surveillance system for bioterrorist and natural disease threats. In Program and Abstracts of the International Conference on Emerging Infectious Diseases, 2002 (p. 31), Abstract retrieved March 11, 2007 from http // www.cdc.gov/iceid/program.htm... 

Define modifications to the agency s internal command notification and coordination structure that are required for BT response. 

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