加拿大修訂國內(nèi)物質(zhì)清單里氏木霉ATCC 74252相關內(nèi)容

Column 1

Living organism

Column 2

Significant new activity for which living organism is subject to subsection 106(3) of the Act

Trichoderma reesei ATCC 74252 S′

1. Any activity involving the living organism in Column 1, opposite to this section, other than

· (a) its submerged fermentation in the absence of light with no solid plant material or insoluble substrate present;

· (b) its use as a research and development organism, as this expression is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms); or

· (c) its culture in a vessel where it is inactivated prior to or upon removal from the vessel and all solid and liquid wastes from the living organism are incinerated.

2. For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the commencement of the proposed significant new activity:

· (a) a description of the proposed significant new activity in relation to the living organism;

· (b) the information specified in paragraphs 1(a) to (g), sections 2 and 3, paragraphs 4(a) and (c), and sections 7 and 9 of Schedule 1 to the New Substances Notification Regulations (Organisms);

· (c) the data and report from a study conducted to determine the identity and quantity of peptaibols produced by the living organism and present in any liquid culture medium in the course of the significant new activity;

· (d) if the study in paragraph (c) shows that peptaibols are produced by the living organism or present in liquid culture medium:

o (i) the data and report from a study conducted to determine the effects of the living organism, in conditions where it produces peptaibols, on aquatic and terrestrial invertebrate species likely to be exposed to it in the course of the significant new activity; and

o (ii) the data and report from a study conducted to determine the effects of peptaibols produced by the living organism on aquatic and terrestrial invertebrate species likely to be exposed to them in the course of the significant new activity;

· (e) all other information and test data in respect of the living organism and its secondary metabolites that are in the possession of the person proposing the significant new activity, or to which they may be reasonably expected to have access, and that are relevant to identifying the hazards of the living organism and its secondary metabolites to the environment and human health and the degree of environmental and public exposure to the living organism and its secondary metabolites;

· (f) the identification of every government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the living organism and, if known, the agency’s file number, the outcome of the assessment, and the risk management actions in relation to the living organism imposed by those agencies;

· (g) the name, civic and postal addresses and telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf;

· (h) the name, civic and postal addresses and telephone number and, if any, fax number and email address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and

· (i) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.

3. The studies described in paragraph 2(c) and subparagraph 2(d)(ii) must be conducted in conformity with the practices described in the OECD Principles of Good Laboratory Practice set out in Annex 2 of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, and that are current at the time the studies are conducted.

4. The studies described in
subparagraph 2(d)(i) must be conducted according to the Environment and Climate Change Canada report EPS 1/RM/44 titled Guidance document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms.

5. The above-mentioned information will be assessed within 120 days after the day on which it is received by the Minister.