Known to or reasonably ascertainably

Testing and Other Risk Data.(17) TSCA 5(d)(1)(B) (C) required each PMN to contain any (i.e. all) health and environmental effects data that the notice submitter has in his "possession or control," as well as a "description" of other data that are "known to or reasonably ascertainable" by him. Thus, a company must provide EPA all test data that it has developed or otherwise obtained concerning its new chemical, and must inform the Agency concerning any other similar data of which it is aware. However, TSCA does not require companies to perform tests or otherwise develop specific data, as a prerequisite to the submission of PMN s. (J 8 )... 

Information Concerning Production, Use, and Commercial Development. TSCA 5(d)(1)(A) requires each PMN to include information concerning the new substance s (proposed) categories of use, production volumes (by category of use), byproducts from production and use, estimated exposure to workers, and disposal methods. As with toxicity data, this production and use information must be provided only to the extent that it is "known to or reasonably ascertainable" by the notice submitter. Because the PMN is submitted prior to manufacture for non-R D purposes, most of this information will be prospective in nature, and it therefore will be expressed either in estimated ranges (where it is quantifiable at all) or in other, more qualitative terms.(15)... 

Submit lists of health and safety studies conducted or initiatied or known to, or reasonably ascertainable and when required submit actual copies of studies... 

Information must be reported for each reportable chemical substance on a separate form for each site for which the submitter is required to report. Information must be submitted to the extent the information is known to or reasonably ascertainable by that person. The additional information that is required to be submitted for substances manufactured or imported at any site in quantities of three-hundred pounds or more during the reporting... 

For each chemical substance, the report must contain the specific chemical name and CAS Number or a PMN case number if a CAS Number is not known to or reasonably ascertainable by the submitter or, for confidential substances, an EPA-designated Accession Number and a code designating which identification number is being used. The report must state whether the substance, by site, is made in or imported into the United States or both and whether it is site-limited. The total volume, in pounds, must be reported for each substance at each site, separately for manufacture and for importation. The rule specifies that the amount must be reported to two significant figures provided that the reported figures are within 10 percent of the actual volume. ... 

Known to or reasonably ascertainably by is defined as all information in a person s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. ... 

Information known to or reasonably ascertainable by the submitter also includes information in its possession or control, which goes beyond the standard meaning ... 

Id. Very confusingly, the regulations define known to or reasonably ascertainable by the submitter to be known to any of its employees or other agents who are associated with the research and development, test marketing, or commercial marketing of the substance for the purposes of this section only. 

Note that signing the PMN form requires signing a certification that the form is complete and includes all test data in the applicant s possession or control and a description of all other data known to or reasonably ascertainable by the applicant. This certification would not be required if the application were submitted in letter format. 

To allow the US EPA to consider potential risks from exposure, the PMN must also include "all existing health and environmental data in the possession of the submitter, parent company, or affiliates, and a description of any existing data known to or reasonably ascertainable by the submitter" (40 CFR 720.40(d)). TSCA does not specify a minimum "base set" of required data and PMNs have often contained few data. In a survey of the PMNs submitted between 1979 and 1985, the US EPA found that 44% of the 5,500 submittals contained some toxicological data (typically on acute toxicity) 9% contained some ecotoxicological data (again, typically on acute toxicity), and only 6% contained information on biodegradability. Fifty-four percent contained no test data. Trends circa 1997 were similar [36]. 

For TSCA purposes, SRU names are used only for several types of common polymer backbones in which the structure of the polymer is known or reasonably ascertained to consist of repeating units instead of being random, and where there is a reported average number of SRU, a variable range of SRU, or an unknown number of SRU. Polymers identified with SRU names on the Inventory include certain polyethylene glycols and derivatives, certain polypropylene glycols and their derivatives, and siloxanes and silicones. 

TSCA 8(d) requires the EPA to promulgate rules requiring manufacturers, importers, processors, and distributors to submit lists and copies of unpublished health and safety studies on specified chemicals or mixtures. Those studies must be listed or submitted if they were conducted or initiated by or for the manufacturer, importer, processor, or distributor, known to such person, or reasonably ascertainable by such person. The intent of the regulations is to give EPA information to determine the need to issue test rules under TSCA 4, restrictions on use under TSCA 5, or prohibitions on the manufacture, use or distribution pursuant to TSCA 6 on the basis that the chemical substance or mixture presents an umeasonable risk of harm to human health or the environment. 

PMN Information. PMN submissions must be made on a standardized Agency form (5) the information must be supplied by PMN submitters to the extent that it is known or reasonably ascertainable. The information requested by the form is... 

Trade secret protection is probably the weakest of all intellectual property rights. The US Uniform Trade Secret Act defines a trade secret as information, including a formula, pattern, compilation, program device, method, technique, or process, that (1) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use and (2) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy [33]. 

Virtually all measurements of d—d spectra of heteroatoms have been made on solutions at room temperature (20, 42—44, 50, 114, 183—186), and no transmission data for single crystals or glasses at low temperatures are available. Moreover, some expected transitions are obscured for the reasons explained earlier or because they lie well into the infra-red (e.g. the 4T2 - 4A2 band of CoirWi204o (50)) in a region where absorption by solvent interferes. Therefore, even when the chromophore is known to have symmetry close to O or T, the desirable excess of data over the number of parameters to be ascertained is not always achieved and it may be necessary to assume that the Racah B parameter is invariant for all states of a given complex or that the free ion C/B ratio is applicable. In addition to all this, we are dealing with several structural classes of anions not surprisingly, therefore, we have not found it possible to fit closely our estimates of A and B35 from published frequencies of spin-allowed bands to the Eq. (187)... 

A) insofar as known to the person submitting the notice or insofar as reasonably ascertainable, the information described in subparagraphs... 

B) in such form and manner as the Administrator may prescribe, any test data in the possession or control of the person giving such notice which are related to the effect of any manufacture, processing, distribution in commerce, use, or disposal of such substance or any article containing such substance, or of any combination of such activities, on health or the environment, and (C) a description of any other data concerning the environmental and health effects of such substance, insofar as known to the person making the notice or insofar as reasonably ascertainable. 

The use of sensitizing dyes in photography has been the subject of many studies and constitutes. still now. one of the most studied areas in specialized periodic publications (125, 126) or in textbooks (88. 127). It can be ascertained that one hundred years after Vogel s discovery of spectral sensitization, the basic mechanisms of action of dyes on their silver halide support still remain not fully understood. However, the theoretical reasons explaining why among many other dye families practically only cyanine methine dyes appear to be spectral sensitizers (128) are better known. 

It is relatively easy to spot variation or an error in the addition of IS for CS and QC samples. As their concentrations are known, large variations in internal standard addition for CS and QC samples would result in the rejection of the CS or QC samples, even a whole run. However, the variation or error in IS addition for unknown incurred samples would be difficult to be ascertained unless the addition of the internal standard is doubled or missed (Fig. 8). Even when a doubled or near zero IS response is observed, there could be other reasons than the addition of the IS. For example, missed addition or incorrect amount of a derivatization reagent can produce near zero IS response as well. 

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