Timing of notification

Knowledge of incident limited at time of notification, leading to possible inaccuracies... 

CFR355.40(b)(2) 4.3.11.1 The notice required under this section shall include the following to the extent known at the time of notification and so long as no delay in notification of emergency response results a) The chemical name or identity of any substance involved in the release. b) An indication of whether the substance is an extremely hazardous substance. 

Regulatory compliance reports (including the date and time of notification). 

Drug testing may be performed at any time while the driver is at work for the employer. The driver may be doing clerical or mechanical repair duties at the time of notification by the employer. 

The employer must ensure that drivers selected for random tests proceed immediately to the testing site upon notification of being selected. If the driver is performing a safety-sensitive function, other than driving a commercial motor vehicle, at the time of notification, the employer must ensure that the driver ceases to perform the safety-sensitive functions and proceeds to the testing site as soon as possible. 

The driver has 72 hours from the time of notification to request the test of the split specimen. The request may be verbal or in writing. 

You cannot use a DOT drug or alcohol testing form just in case circumstances change requiring a test (i.e., driver cited within 8 and 32 hours respectively, or a fatality occurs as a result of the accident). This is a misrepresentation of the test to the driver since the criteria for DOT testing was not met at the time of notification. 

Printed Patent Office Gazettes. The issuance of patents is announced by patent offices ia pubHcations typically known as ga2ettes and bulletins, which are pubHshed most commonly at the time of the patent s pubHcation, but there are exceptions. Advance information is pubHshed ia a patent ga2ette by some countries prior to the pubHcation of patent documents, typically as a notification of filing details. However, some patent ga2ettes do not appear until weU after the effective pubHcation date of the patents they announce. 

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)... 

Chemical manufacturers submitted 1,031 Premanufacture Notifications in 1980 and 1981. In the same time period, they submitted 290 notifications of commencement of commercial manufacture. In other words, only 28)1 of the substances for which Premanufacturing notices were filed in the past two years of compliance have become commercial. Specifically, for the reactive polymer segment, about 29% of the reported substances have become commercial. These percentages indicate that much of what has constituted the impacts of TSCA has been "protective" filing of notifications. The length and complexity of the process mandated by TSCA has led to unnecessary resource diversion. A more liberal definition of what constitutes a commercial event could have significantly increased the percentages and reduced this type of impact, at least since July, 1979. 

The format and timing of all external notifications should be identified and incorporated into the incident investigation management system before an incident. With this information readily at hand, the proper notifications may be made quickly and accurately when an incident occurs. 

Under the TSCA, a new chemical is a chemical substance that is not already included on the TSCA Inventory, and is intended to be used for a commercial purpose (other than as a drug or pesticide) in the USA. Section 5 of the TSCA requires manufacturers or importers of a new chemical to notify the EPA (i.e., submit a premanufacture notification, PMN) before manufacturing or importing the chemical. The EPA has only 90 days (extendable to 180 days under certain circumstances) from the time of receipt of the notification to determine if an unreasonable risk may or will be presented by any aspect of the new industrial chemical, and make risk management decisions and take action to control any unreasonable risks posed by the chemical [17]. If after 90 days the submitter of a new chemical is not notified by the EPA of any regulatory restrictions or test requirements, they can legally market or import the chemical. 

Pollution level identification of zones and areas with levels above the limit values for PM10 and NO2 in 2007. Sources of information were the annual reports submitted according to Commission Decision 2004/461/EC [3], AirBase,1 time extension notifications,2 model calculations (e.g. EMEP3) and reports from ETC/ACC.4 Further, mostly qualitative information was derived from Europe-wide modelling and earth observation studies. 

Trends identification of zones and areas with stagnant or increasing PM, NOx and NO2 levels. Sources of information were annual reports (2004/461/EC), AirBase and time extension notifications. Separate analysis of the trends of NOx and NO2 levels helps to identify areas influenced by increasing primary N02 emissions from diesel vehicles. 

The latter criteria excluded southern Spain, as no air quality plans and time extension notification were available at the time of writing. 

To expedite the launch of a new chemical and allow further time to complete the toxicological package for full registration, at first a limited announcement can be filed with a notification time of 30 d. By this procedure, however, not more than 1 t/a of the chemical is allowed to be sold in the EU. 

Another requirement of Superfund is that notification of a hazardous substance release (in reportable quantities) must be made at the time of the release - failure to report is treated as a felony. 

At the time of the FDA s pre-approval inspection (our first) of the Chemical Development dilevalol DBTA manufacturing operation (dilevalol hydrochloride itself was manufactured in Schering s Ireland facility), Chemical Development received an FDA 483 notification stating that the full-time use of the butanol/water recrystallization process for dilevalol DBTA salt was in violation of the NDA. The NDA stated that the recrystallization process was registered for use only when the first crystallization of the DBTA salt gave a product outside specification the FDA interpreted this to mean no more than about 10% of the time. Since the process had evolved... 

Section 120 of FDAMA amended section 505 of the FD C Act by adding section 505(n). This new section includes provision for the following (a) additional members to be included in new advisory committees, (b) new conflict of interest considerations, (c) education and training for new committee members, (d) timely committee consideration of matters, and (e) timely agency notification to affected persons of decisions on matters considered by advisory committees. 

The scope of a disaster can vary greatly and is partially dependent on the location of the disaster. A disaster in a rural community may not be considered a major event in an urban area because of the greater resource availability characteristic of urban areas. Conversely, an event that would have an impact in an urban setting may have next to no impact in rural areas because of low population densities. State, regional, and federal support does exist and will likely be made available in the event of a disaster (Richards, Burstein, Waeckerle, Hutson, 1999). However, because a required chain of notification must be completed to obtain outside support and because it takes time for state or federal officials to marshal the proper resources, disasters are usually local for the first days (Auf der Heide, 1989, 2006 Kaji Waeckerle, 2003), which was exemplified by the federal response to Hurricane Katrina. After the first few days, the extent of the support may be limited by the nature of the disaster. A widespread infectious epidemic may require that... 

The existing, small differences between the Hungarian and EU rules (e.g., two-year approval time, no notification system for variations) will be abolished only at the time of Hungarian admittance to the EU. 

The standard periods for the review of a new application from the day of the receipt by the local government until the approval by the MHW are specified as follows (Notification No. 960 in 1985, No. 240 in 1986 and No. 26 in 1990 of the PAB). This period excludes the time required for preparing replies to the questions given by the health authority. However, it is anticipated to shorten the review time of new drugs to 12 months from April 2000 by revision of the review system such cis elimination of the subcommittees for new drugs. 

In case of addition of manufacturing to import or changes from import to manufacturing, bioequivalence data can be omitted for drugs with the same formulation or manufacturing process as before the addition or changes. A document certifying that the manufacturer has obtained all of the data and information should be submitted. Manufacturer must confirm by suitable tests that quality, efficacy and safety are secured and must retain the relevant documents. For a stability, a relative comparative test is acceptable to carry out by the time of approval (Notification No. 43 of the PAB 1991, etc.). 

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