Possession or control

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 )... 

Another provision of interest to chemists is the compulsory filing of a patentability brief, wherein the inventor discusses pertinent literature references and other background information and explains why his invention is patentable in the fight of this background. This requirement for a patentability brief is not in itself disadvantageous. It does, however, present risks to the patent applicant when considered in the context of other provisions of S.2255, particularly that which requires that the inventor, the assignee, and the attorney investigate all sources of information within their possession or control—this surely means within all... 

Both the terms possession or control and reasonably ascertainable are defined terms that will be discussed infra. 

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 ... 

Possession or control means in possession or control of the submitter, or of any subsidiary, partnership in which the submitter is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the submitter in the research, development, test marketing, or commercial marketing of the chemical substance in question. (A parent company owns or controls another company if the parent owns or controls 50 percent or more of the other company s voting stock A parent company owns or controls any partnership in which it is a general partner). Information is included within this definition if it is ... 

Under this definition, a person submitting a PMN must search for all relevant information in its possession or control in the following places ... 

Any entity that has a research agreement with the submitter or one of the entities that has information in the possession or control of the submitter should be considered an entity that is associated with the submitter, although there is no formal guidance on this point. 

Test data in the submitter s possession or control must be submitted with the PMN. That term is defined as data from a formal or informal test or experiment, including information concerning the objectives, experimental methods and materials, protocols, results, data analyses, recorded observations, monitoring data, measurements, and conclusions from a test or experiment. Test data that is not in the submitter s possession or control must be described in the PMN if it is reasonably ascertainable. ... 

All test data in the PMN submitter s possession or control, as that term is defined in the regulations, that relate to effects on health or the environment caused by manufacturing, processing, distributing in commerce, use, or disposal of the PMN substance or any mixture, formulation, or article containing it must be submitted with the PMN form, with some limited exceptions discussed below. Note that test data must only be submitted if it is within the submitter s possession or control and there is no obligation to search for all information that a reasonable person in the same situation might be expected to know. Test data that must be submitted with a PMN includes ... 

As a practical matter, it makes much more sense to perform R D in a laboratory that meets these requirements. A researcher in a non-qualifying laboratory needs to conduct a thorough evaluation of risk information in the company s possession or control for each new R D substance before it makes or imports (or processes if there is a SNUR) the substance. So long as the chemical identity of the R D substance is known, it will be possible to conduct that risk evaluation and determine if a SNUR applies. 

A TERA must be filed at least sixty days before the research and development begins. The EPA will either approve the TERA, with or without imposing conditions, or reject it. A TERA must include details of the plaimed R D information on confinement, mitigation, and emergency termination and health and environmental effects data in the submitter s possession or control. The EPA has sixty days to review a TERA, but the submitter may not proceed without written authorization from the EPA. ... 

Two or more companies can file one SNUN together if they are both obligated to file a SNUN. All the companies that file the SNUN must sign the certification portion of the PMN form. Each remains individually responsible for searching for relevant information in its possession or control or reasonably ascertainable by it. ... 

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. 

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. 

Your notification must inform users of any information in your possession or control on the risk to health from such exposure, or must state that no information is known about the toxicity of the substance. 

All prior written medical opinions concerning the employee in the employer s possession or control. 

The employer must provide examining and consulting physicians with the following specific information a copy of the lead regulations and all appendices, a description of the employee s duties as related to exposure, the exposure level or anticipated level to lead and any other toxic substances (if applicable), a description of personal protective equipment used, blood lead levels, and all prior written medical opinions regarding the employee in the employer s possession or control. The employer must also obtain from the physician and provide the employee with a written medical opinion containing blood lead levels, the physicians s opinion as to whether the employee is at risk of material impairment to health, any recommended protective measures for the employee if further exposure is permitted, as well as any recommended limitations upon an employee s use of respirators. 

Permit entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspection and measuring, photographing, testing, or for other purposes as stated in paragraph (a)(1). 

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