Title 40
SECTION 725.355
725.355 Information to be included in the TME application.
§ 725.355 Information to be included in the TME application.(a) To review a TME application, EPA must have sufficient information to permit a reasoned evaluation of the health and environmental effects of the planned test marketing activity. The person seeking EPA approval must submit all information known to or reasonably ascertainable by the person on the microorganism and the test marketing activity, including information not listed in paragraphs (c), (d), and (e) of this section that the person believes will demonstrate that the microorganism will not present an unreasonable risk of injury to health or the environment as a result of the test marketing. The TME application must be in writing and must include at least the information described in paragraphs (b), (c), (d), and (e) of this section.
(b) When specific information is not submitted, an explanation of why such information is not available or not applicable must be included.
(c) Persons applying for a TME must submit the submitter identification and microorganism identity information required for MCANs in § 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TME must submit phenotypic and ecological characteristics information required in § 725.155(d)(3) as it relates directly to the conditions of the proposed test marketing activity.
(e) Persons applying for a TME must also submit the following information about the proposed test marketing activity:
(1) Proposed test marketing activity. (i) The maximum quantity of the microorganism which the applicant will manufacture or import for test marketing.
(ii) The maximum number of persons who may be provided the microorganism during test marketing.
(iii) The maximum number of persons who may be exposed to the microorganism as a result of test marketing, including information regarding duration and route of such exposures.
(iv) A description of the test marketing activity, including its duration and how it can be distinguished from full-scale commercial production and research and development activities.
(2) Health and environmental effects data. All existing data regarding health and environmental effects of the microorganism must be reported in accordance with § 725.160.