Determining reporting requirements under

It is almost too obvious to state that companies should be aware of chemical substances that they manufacture or import, but in fact this is often not the case, and is where a compliance problem arises. The regulatory requirements are typically published by chemical name and Chemical Abstracts Service (CAS) Number, whereas in many companies trade names are more commonly used when tracking chemicals. The Material Safety Data Sheet (MSDS) system most often is the easiest place to determine whether a product or an isolated intermediate contains a component that is subject to regulation. With respect to imports, they should be cleared by a regulatory review prior to importation not only for general TSCA compliance, but also to ascertain whether or not there are any TSCA reporting requirements under TSCA... 

To determine whether you are required to report under section 313, you must ascertain whetherthe total quantity of any listed chemical orchemical compound manufactured, processed, or used at your facility over the course of the calendar year exceeds any applicable threshold. For the facility described above, determination of reporting requirement would proceed as follows. (Note In determining eligibility, you will generate Information you need to complete several portions of the form.)... 

Most of the provisions of the Toxic Substances Control Act (TSCA) of 1976 (PL 94-469) rely in some way on risk assessment of chemicals. Under the reporting requirements of the statute, any manufacturer, processor, or distributor of a chemical for commercial purposes must inform the EPA immediately after discovering any information which "reasonably supports the conclusion" that a chemical substance or mixture "presents a substantial risk of injury to health or to the environment" unless the EPA Administrator has been adequately informed already. EPA is mandated to establish regulations for testing new or existing substances when it is determined that there is not enough health or environmental information, that testing is necessary to develop such information and that the chemical or mixture "may present an unreasonable risk of injury to health or the environment."... 

SARATRAX irr Research Institute, Maryland Technology Center Dr. Quon Y. Kwan Sr. Bnv. Engineer 4600 Forbes Blvd Lanham, MD 20706 (800) 458-1564 (301) 459-3711 Assists with determination of facility reporting responsibilities under Sections 301-303, 304, and 311-312. Assists with notiHcation requirements and dcHnitions of responsibilities. Maintains lists of chemicals, quantities, locations, and properties to assist with the preparation of Tier 1 and Tier II reports. Generates Form R. 

The FDA has mandated that laboratories using ASRs must label their reports with the statement, This test was developed and its performance characteristics determined by (laboratory name). It has not been cleared or approved by the U.S. Food and Drug Administration. LDTs that use primers and probes made in the laboratory are not covered by this rule. The College of American Pathologists (CAP) has suggested additional language to reflect the fact that FDA review is not required under this regulation. 

EPA has designated a list of specific petroleum process stream chemicals by CAS Number in the rule as exempt from certain information requirements under the lUR. That specific list should be consulted to determine the status of any particular petroleum process stream. The petroleum process stream partial exemption was established by the 2003 Amendments to the lUR and was based upon expected exposures and uses. EPA determined that those chemicals were transported, processed, and stored in well controlled vessels because they are flammable. For that reason, EPA believed worker exposure was diminished, so the substances would not warrant the full set of reporting data. °° In the final rule dealing with petroleum process streams for the 2006 lUR, EPA made clear its intention to revisit the list for the next reporting cycle. 

Id. The EPA sporadically polls testing labs to determine if there is sufficient capacity to perform tests required under TSCA. See EPA Census of TSCA Testing Laboratories, Final Report (Oct 10, 1996). 

As discussed in Chapter 7, Reporting and Recordkeeping, 8(e) of the Toxic Substances Control Act (TSCA) requires that any person who imports, manufactures, processes, or distributes chemical substances or mixtures in the United States and who obtains information generated in the United States or in another country that reasonably supports a conclusion that a chemical substance or mixture may present a substantial risk of injury to human health or the environment must immediately report such information to the United States Environmental Protection Agency (EPA), unless the person knows that EPA has already been adequately informed. The information must be submitted to the Agency within thirty calendar days of the individual or business obtaining the information. For information to be reportable under 8(e), it does not need to establish conclusively that a risk exists and does not need to provide evidence that the substance is hazardous to human health or the environment under actual conditions of use and exposure. The information may relate to actual instances of serious human health or environmental injury caused by the chemical or mixture or to observations that are early indications of such effects. Incidents of environmental contamination may also be report-able under TSCA 8(e) and should be reviewed under this procedure in order to determine its immediate reportability as soon as the Company has knowledge of the incident. 

Step 8. The MPC shall also determine if the presence of the subject chemical in the United States will trigger a chemical specific reporting requirement, and if so will gather and submit the required information as required under (insert relevant procedure reference such as the procedure for compliance with TSCA substantial risk reporting. The MRC will update the product database to reflect this information. 

Under pressure to provide interim guidance, particularly under the Toxic Substance Control Act (TSCA), EPA in July 2007 issued guidance on determining whether a new nanoscale material is considered an existing chemical covered by inventory listing or a new chemical subject to Premanufacture Notification (PMN) reporting requirements. Specifically, are nanomaterials automatically considered New Chemicals under the TSCA or may they be considered as Existing Chemicals ... 

CERCLA To fidfill requirements under CERCLA, the person in charge of the vessel or facility must report the release of a hazardous substance to the NRC at (800) 424-8802, as soon as it is determined that an RQ has heen released into the environment and... 

A major factor which determines the requirement for a column process is that of sanitary operating conditions. In order to operate a process under these conditions a closed system is ideal and this may preclude the use of batch process unless a suitable self-contained plant operating area is available. A more detailed discussion of the factors listed in lkble6-l has been reported elsewhere [12]. 

In 1883, Bottinger described the reaction of aniline and pyruvic acid to yield a methylquinolinecarboxylic acid. He found that the compound decarboxylated and resulted in a methylquinoline, but made no effort to determine the position of either the carboxylic acid or methyl group. Four years later, Doebner established the first product as 2-methylquinoline-4-carboxylic acid (8) and the second product as 2- methylquinoline (9). Under the reaction conditions (refluxing ethanol), pyruvic acid partially decarboxylates to provide the required acetaldehyde in situ. By adding other aldehydes at the beginning of the reaction, Doebner found he was able to synthesize a variety of 2-substituted quinolines. While the Doebner reaction is most commonly associated with the preparation of 2-aryl quinolines, in this primary communication Doebner reported the successful use of several alkyl aldehydes in the quinoline synthesis. 

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