Health notification

Public health notification. In this case, the first indication that chemical contamination or a chemical emergency (e.g., chemical burns) has occurred is the appearance of victims in local emergency rooms and health clinics. Chemical facilities may therefore be notified, particularly if the cause is unknown or linked to chemicals. An incident triggered by a public health notification is unique in that at least a segment of the population has been exposed to a harmful substance. If this agent is a chemical (including biotoxins), then the time between exposure and onset of symptoms may be on the order of hours, and thus there is the potential that the contaminant is still present. 

FDA Public Health Notification issued August 13, 2009 Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology. http //www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ PublicHealthNotifications/ucml76992.htm, accessed April 15,2010. 

U S. Food and Drug Administration, Center for Devices and Radiological Health, FDA Public Health Notification PVC Devices Containing Plasticizer DEHP, July 2002. 

D W Feigl, FDA PubUc Health Notification. Problem with endovascular grafts for... 

Public Health Notification Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment (2007 FDA)... 

Public Health Notification from FDA, CDC, EPA, and OSHA Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment (October 31, 2007) describes problems such as equipment fire and malfunction and healthcare worker burns resulting from inappropriate use of cleaning and disinfecting liquids on electronic medical equipment. 

FDA and NIOSH Public Health Notification Oxygen Regulator Fires Resulting from Incorrect Use of CGA870 Seals (June 19,2006) alerts healthcare professionals and the public about a potential occupational hazard associated with the improper use of oxygen regulator gaskets. 

Many countries have adopted chemical substance iaventories ia order to monitor use and evaluate exposure potential and consequences. In the case of essential oils used in many fragrance appHcations, these oils must be on many of these Hsts. New essential oils used in fragrances are subject to premanufactuting or premarketing notification (PMN). PMN requirements vary by country and predicted volume of production. They require assessment of environmental and human health-related properties, and reporting results to designated governmental authorities. 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

Are there other environmental or health and safety reviews or approvals (for example, need for public hearings, notification, registrations) which need to be obtained If yes, how long will it take to secure these approvals If yes, explain. 

The required notification must be provided at ieast annually In writing. Acceptable forms of notice are, for example, a letter, product labeling, and product literature distributed to customers. If you are required to prepare and distribute a Material Safety Data Sheet (MSDS) for the mixture under the Occupational Safety and Health Act (OSHA) Hazard Communication Standard, your section 313 notification may be attached to the MSDS or the MSDS may be modified to include the required information. (A sample letter and recommended text for inclusion in an MSDS appear on pages E-4 and E-5 of this appendix.)... 

Emergency notification should include chemical name and identification of the chemical by number estimation of quantity released time and duration of release mode of release (air, water, or soil) known health risks associated with the emergency applicable precautions and name and phone number of a contact person. All emergency notifications require a written follow-up as soon as possible [2]. 

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. 

The patient verbalizes an understanding of die therapeutic regimen and adverse effects requiring notification of the primary health care provider. 

Based on the Notification of March 15,2001 and the newest Notification of June 3, 2008 from the Department of Food Safety, Ministry of Health, Labor, and Welfare (MHLW) of Japan. 

Notification No. 1106001 of November 6, 2002, and the revised Notification No. 0622003 of June 22, 2006, Department of Food Safety, the Ministry of Health, Labour and Welfare of Japan. 

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. Center for Devices and Radiologic Health, FDA, Rockville, MD, 1997. 

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... 

Preliminary assessments have been conducted at more than 31,000 sites reported as possible sources of contamination. In 1990 there were over 1100 sites (presenting the greatest health risk and hence eligible for Superfund reimbursement) on the NPL.8-9 The NCP has outlined the level of cleanup necessary at Superfund sites and established the basic procedures that have to be followed for the discovery, notification, response, and remediation of the hazardous waste sites.10... 

Lists of field-test notifications in the European Union, the USA, Canada, Australia and Japan respectively. Available from http //engl.jrc/it http //www.nbiap.vt.edu/ http // www.inspection.gc.ca/ http // www.health.gov.au/ogtr/index.htm www. s. affrc.go. jp/docs / sebtan / eguide / edevelp.htm. List of field tests applications for many countries in Asia, South America and Africa are available from http //binas.unido.org/binas/home/ php. 

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. 

As a result of that we got involved with the state s Department of Education to produce an MCS awareness brochure that went out to all the school administrators. That work led to invitations to four pesticide conferences, and to the opportunity to work on drafting regulations for pesticide notification. We also got involved with the Department of Health and participated in an MCS prevalence study working group. One of the outcomes of that was the inclusion of questions regarding chemical sensitivity on a statewide survey. That study revealed that sixteen percent of the population in New Mexico... 

Priority substances were selected, which are considered to be of particular concern to human health and/or the environment. The suppliers of these priority substances had to provide any missing studies to complete a EU notification Base Set (Table 1). A rapporteur Competent Authority evaluates the full review dossier on behalf of the EU. The final output is a risk assessment (see Section 14), with final recommendations on how to deal with the substance i.e., it may be of no concern, require risk reduction or restriction, or further data may be needed before a decision is made. 

Under Article 7(1), if the country that receives a notification concludes that further data and information are needed for performing health and environmental assessments of the new substance, it may require the notice submitter to provide those data. This may involve completion of the Annex VII base set (for PMN s that invoke the "escape clause"), and/or performance of further tests specified in Annex VIII, in addition to those contained in Annex VII.(24) Annex VIII specifies a series of sub-chronic and chronic tests, as well as other extensive (and expensive) data requirements that may be required as a part of followup notifications once a chemical enters commercial production and its production volume increases substantially. 

FDA from the Medwatch Office -Summaries of Dear Health Professional Letters and Other Safety Notifications, www.fda.gov/medbull/ mar97/medwatch.html, last accessed on 16th December 2002. 

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