Unofficial translation
Footnote. Abolished by Order of the Minister of Agriculture of the Republic of Kazakhstan dated November 25, 2022 No. 391 (effective after ten calendar days after the date of its first official publication).In accordance with subparagraph 46-28) of Article 8 of the Law of the Republic of Kazakhstan dated July 10, 2002 "On Veterinary Medicine" I HEREBY ORDER:
1. To approve the attached Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains.
2. The Department of Veterinary, Phytosanitary and Food Safety of the Ministry of Agriculture of the Republic of Kazakhstan, in the manner prescribed by law, shall ensure:
1) state registration of this order with the Ministry of Justice of the Republic of Kazakhstan;
2) posting this Order on the Internet resource of the Ministry of Agriculture of the Republic of Kazakhstan after its official publication.
3. Control over the execution of this Order shall be entrusted to the supervising Vice-Minister of Agriculture of the Republic of Kazakhstan.
4. This Order shall come into effect upon the expiration of ten calendar days after the day of its first official publication.
|
Minister of Agriculture of the Republic of Kazakhstan |
S. Omarov |
| Approved by Order of the Minister of Agriculture of the Republic of Kazakhstan dated March 17, 2020, No. 93 |
The Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains
Chapter 1. General Provisions
1. These Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains (hereinafter referred to as the Rules) have been developed in accordance with subparagraph 46-28) of Article 8 of the Law of the Republic of Kazakhstan dated July 10, 2002 "On Veterinary Medicine" (hereinafter referred to as the Law) and shall determine the procedure for depositing microorganism strains, maintaining the National collection of deposited microorganism strains used in veterinary medicine.
2. Deposition of microorganism strains, maintenance of the National collection of deposited microorganism strains shall be carried out by the republican state enterprise on the right of economic management "National Reference Center for Veterinary Medicine" of the Committee of Veterinary Control and Supervision of the Ministry of Agriculture of the Republic of Kazakhstan (hereinafter referred to as the Organization).
3. The following concepts shall be used in these Rules:
1) depositor - an individual or legal entity that has applied for depositing a microorganism strain;
2) department of the authorized body in the field of veterinary medicine (hereinafter referred to as the Department) - the Committee of Veterinary Control and Supervision of the Ministry of Agriculture of the Republic of Kazakhstan;
3) depositing microorganism strains - transfer of a microorganism strain to an organization, registration, storage, and delivery of a sample of a microorganism strain to interested parties;
4) culture of a microorganism - a set (population) of viable microorganisms grown on a nutrient medium;
5) strain - a pure culture of a microorganism.
4. The costs of storing microorganism strains in the National Collection of deposited microorganism strains used in veterinary medicine shall be financed from budgetary funds in accordance with subparagraph 7) of paragraph 1 of Article 35 of the Law.
5. Deposition of microorganism strains used in veterinary medicine, which are not subject to storage in the National Collection of Deposited Microorganism strains, shall be carried out at the expense of the depositor in accordance with subparagraph 6-2) of paragraph 2 of Article 35 of the Law.
6. The organization shall accept for deposit the causative agents of animal diseases (bacteria, viruses, pathogenic fungi, protozoa) used in veterinary medicine, as well as those obtained as a result of scientific research and in the diagnosis of animal diseases.
Chapter 2. Procedure for depositing microorganism strains
7. Depositing microorganism strains in the organization shall be carried out by depositors.
8. The procedure for depositing shall be divided into initial and re-depositing.
Paragraph 1. Initial depositing procedure
9. To deposit a microorganism strain, a depositor shall apply to deposit a microorganism strain in the form in accordance with Annex 1 to these Rules.
The following documents shall be attached to the application:
a petition for depositing a microorganism in the form in accordance with Annex 2 to these Rules;
passport of the microorganism strain transferred for deposit in the form in accordance with Annex 3 to these Rules;
passport of the virus strain transferred for deposition in the form in accordance with Annex 4 to these Rules;
if necessary, methodological recommendations (instructions, rules) with a complete and detailed description of the studies of the microorganism strain (progress of work, manipulations);
a document confirming the genetic characteristics of the deposited strain of the microorganism;
the strain of the microorganism.
To receive a microorganism strain, by the decision of the head of the organization or the person performing his duties, a commission shall be created.
The commission, within 3 (three) working days from the date of receipt of the microorganism strain, shall check the condition of the package, the conformity of the enclosed material to the application, its appearance and draw up a corresponding act in any form, one copy of which shall be sent to the depositor's address.
10. When transferring a microorganism strain to an organization, the following requirements shall be observed:
1) the strain of the microorganism shall be presented in a lyophilized or frozen (cryo-preserved) or a native state with observance of the temperature regime during transportation, depending on the strain of the microorganism (confirmed by temperature sensors or other devices);
2) ampoules (vials), test tubes containing the deposited material shall be hermetically sealed and supplied with labels with the name of the microorganism strain, date of manufacture.
11. The deposited microorganism shall be transferred to the organization in quantity and form based on practical and scientific needs. The number of containers (test tube, vial, ampoule, cryovial) for viruses shall be at least ten, for bacteria - at least five, for pathogenic fungi - at least five.
12. Microorganism strains corresponding to the following properties shall be transferred for deposition:
have an antigenic structure typical of the species (family, genus, serovar);
correspond to morphological, cultural, enzymatic characteristics;
have rather apparent useful properties (high infectious and antigenic activity, immunogenicity);
have the ability to cultivate on artificial nutrient media or in the body of naturally susceptible animals (bird embryos), cell culture without changing the original biological properties.
13. A microorganism strain shall not significantly lose its original biological properties within 5 (five) years, subject to the temperature storage regime.
14. The microorganism strains entering the deposit are subject to mandatory checks for purity and viability.
15. The microorganism strains deposited in the organization shall be registered in the register of the movement of microorganism strains used in veterinary medicine in the form according to Annex 20 to the Order of the Minister of Agriculture of the Republic of Kazakhstan dated February 25, 2014, No. 16-07/114 "On approval of forms of veterinary accounting and reporting" (registered in the State Register of Normative Legal Acts under No. 9342) using binomial Latin names, reflecting their belonging to certain genera and species.
Registered systematic groups of microorganisms have the following designations: B - bacterium, AV - animal virus, BV - bacterial virus (bacteriophage), P - protozoa, F - pathogenic fungus.
16. When depositing a microorganism strain, a collection number shall be assigned. The collection number assigned to a microorganism strain shall not change during transmission.
If a microorganism strain is lost (written off), it shall be prohibited to assign its collection number to another microorganism strain.
17. After establishing the viability and purity of the strain of the microorganism, but no later than two months after the date of transfer of the strain of the microorganism, the organization shall issue a certificate of deposit to the depositor in the form in accordance with Annex 5 to these Rules.
The certificate of deposit shall be accompanied by a passport of the collection strain of the microorganism in the form in accordance with Annex 6 to these Rules.
For microorganism strains accepted for storage and passed the deposit procedure, the organization shall fill out an information card in the form in accordance with Annex 7 to these Rules.
18. The deposit shall be considered complete from the moment the deposit certificate is sent to the depositor in the form in accordance with Annex 5 to these Rules.
19. The organization shall refuse to deposit a microorganism strain if:
1) the properties of the microorganism are so exceptional that the organization is technically unable to carry out its functions;
2) the material was obtained in a state that indicates that the microorganism is absent, or the presented culture of the microorganism is not viable, or it contains the presence of contamination (contamination) by foreign microorganisms;
3) the strain does not meet the requirements of viability and purity. In this case, the depositor is allowed to repeat the deposit procedure.
20. In case of loss of a strain of microorganism viability, the organization, within five working days from the date of establishment of the fact of loss, shall send a written notification to the depositor indicating the reason for the loss and with a proposal to re-deposit the strain of the microorganism.
21. If there is no response within a month after sending the corresponding notification or the strain of the microorganism to the depositor, the strain shall be written off.
Paragraph 2. Procedure for re-depositing
22. Re-deposition shall be carried out in case of loss of the deposited strain of the microorganism viability.
23. A depositor for re-depositing a microorganism strain to the organization shall submit a written application for re-depositing a microorganism strain in the form in accordance with Annex 8 to these Rules.
The following shall be attached to the application:
copy of the certificate of deposit;
the strain of the microorganism.
24. When re-depositing, the strain of the microorganism shall be checked for purity and viability, and the depositor shall be reissued a certificate of deposit in the form in accordance with Annex 5 to these Rules.
When re-depositing, a copy of the certificate of the viability of the deposited microorganism in the form in accordance with Annex 9 to these Rules shall be attached to the certificate of deposit.
Paragraph 3. Issuance of a certificate of viability
25. The organization shall check the viability of each strain of microorganism deposited in it:
1) immediately after receiving it;
2) at appropriate intervals, depending on the type of microorganism and possible storage conditions, or at any time if it is necessary for technical reasons;
3) at any time at the request of the depositor.
26. The organization shall additionally check any biological properties (signs) of a microorganism strain, as well as sequencing its genome or a specific region of the molecule of deoxyribonucleic acid, ribonucleic acid to identify genetic markers and develop a genetic passport.
27. The organization, in cases where the determination of viability gives controversial results or when it involves significant technical difficulties, shall involve the depositor in the implementation of the verification.
28. The organization shall issue a certificate of the viability of the deposited microorganism:
1) to the depositor at his request;
2) to an individual or legal entity other than the depositor, to whom the deposited strain of the microorganism was issued upon their official request.
29. The certificate of the viability of the deposited microorganism shall be drawn up in the form in accordance with Annex 9 to these Rules.
Chapter 3. Procedure for maintaining the National collection of deposited microorganism strains
30. Microorganism strains existing in the Republic of Kazakhstan, as well as obtained as a result of scientific research, in the diagnosis of animal diseases, are subject to storage in the National Collection of deposited microorganism strains used in veterinary medicine.
31. The organization shall carry out the deposition of strains in the following forms: deposition for the storage of microorganism strains and national patent deposition of microorganism strains.
Paragraph 1. Deposition for storage of microorganism strains
32. The organization accepts microorganism strains of interest for organizations, developers, and manufacturers of veterinary drugs or research purposes for storage in the National Collection of Deposited Microorganism Strains.
Information on microbial strains stored in the National Collection of Deposited Microbial Strains shall be publicly available.
33. A depositor who has transferred a microorganism strain for storage to the National Collection of Deposited Microorganism strains shall subsequently be allowed to receive a sample of the deposited strain of microorganisms from the organization.
Paragraph 2. National patent deposit of a microorganism strain (deposit to file an application for a scientific invention)
34. National patent deposit of a microorganism strain shall be carried out if it is planned to apply for a patent for a microorganism strain or a method of its use.
35. After establishing the viability and purity of the strain of the microorganism, the depositor shall be issued a certificate of deposit of the microorganism in the form in accordance with Annex 5 to these Rules, indicating the assigned collection number.
36. The implementation of the deposit and information on the deposited strain of the microorganism is confidential, as well as the strain of the microorganism itself until the receipt of a patent and with the consent of the depositor.
Chapter 4. Issuance of microorganism strains from the National collection of deposited microorganism strains
37. Issuance of microorganism strains stored in an organization from the National Collection of Deposited Microorganism strains shall be carried out in agreement with the department and based on an official request from individuals or legal entities, which indicates the purpose of the request for strains.
38. A prerequisite for providing microorganism strains to individuals or legal entities shall be their technical capabilities to work with microorganism strains. Organizations shall be allowed to request appropriate written confirmation.
39. Claims from recipients of microorganism strains to the quality of the transferred material shall be accepted within one month from the date of their issue.
40. The recipient shall use the microorganism strains obtained from the organization exclusively for the purposes specified in the official request.
41. The organization shall issue the deposited strain of the microorganism:
1) to the depositor upon his written request;
2) to an individual or legal entity other than the depositor who submitted an official request and provided that this request is accompanied by the depositor's written permission to issue a sample of the deposited strain of the microorganism with the consent of the authors for use in research work.
42. When issuing a microorganism strain, the organization shall provide the following documentation:
1) a letter of guarantee indicating the type of strain of the microorganism, which is drawn up in any form;
2) an extract from the passport of the collection strain of the microorganism in the form in accordance with Annex 10 to these Rules;
3) an act of transfer of microorganism strains outside the organization in the form in accordance with Annex 11 to these Rules.
43. Release (receipt) of microorganism strains within the organization shall be carried out only with the written permission of the head of the organization with the preparation of an act of transfer of microorganism strains within the laboratory (organization) in the form in accordance with Annex 12 to these Rules and an entry in the relevant journals.
When transferring microorganisms for temporary storage, it is necessary to draw up an act of transfer of microorganisms for (after) temporary storage in accordance with Annex 13 to these Rules.
44. Transportation of microorganism strains shall be carried out in compliance with the Sanitary Rules "Sanitary and Epidemiological Requirements for Laboratories Using Potentially Hazardous Chemical and Biological Substances" approved by Order of the Minister of Health of the Republic of Kazakhstan dated September 8, 2017, No. 684 (registered in the State Register of Normative Legal Acts under No. 15990) and the Rules for the carriage of dangerous goods by road and the list of dangerous goods allowed for carriage by motor vehicles on the territory of the Republic of Kazakhstan, approved by Order of the Acting Minister for Investment and Development of the Republic of Kazakhstan dated April 17, 2015, No. 460 (registered in the State Register of Normative Legal Acts under No. 11779).
Chapter 5. Procedure for storage and refreshment of deposited microorganism strains, including the National collection of deposited microorganism strains
45. Microorganism strains shall be stored in separate rooms, in refrigerators (fireproof cabinets, safes) separately by groups (genera).
Refrigerators, cabinets, safes shall be sealed at the end of the working day.
46. Responsible persons for storage of microorganism strains shall daily control the temperature of storage of microorganism strains.
47. Storage of microorganism strains shall be carried out in accordance with the passport of the collection strain of the microorganism, which also reflects the biological activity and frequency of crops.
48. Containers containing microorganism strains shall have clear, indelible inscriptions or firmly glued labels indicating the name of the strain of the microorganism, collection number, and date of reseeding (lyophilization).
49. The responsible employees shall annually determine, according to the storage card, the microorganism strains to be refreshed.
50. Refreshment works shall be carried out in a "clean" box, where at the time of the study no work is carried out with other microorganism strains.
51. Employees responsible for refreshing microorganism strains shall receive microorganism strains from the organization get acquainted with the passport and available documentary characteristics.
52. The employee responsible for the refreshing of the microorganism strain shall completely maintain the documentation on its movement accounting, prepare an act of opening a container with microorganisms to inoculate or destruction, an act of destroying the microorganism strain in the forms in accordance with Appendices 14 and 15 to these Rules, and based on the results of virus refreshing, a test report shall be drawn up in the form in accordance with Annex 16 to these Rules.
53. Storage of strains by a microorganism in a native form shall be allowed.
54. Freeze-drying (lyophilization) of microorganism strains in ampoules (vials) shall be carried out in the drying apparatus. Pre-freezing shall be carried out either in a low-temperature refrigerator at minus 50-70 degrees Celsius, or in a chamber of a sublimation apparatus. For each strain of the microorganism, the most gentle lyophilization mode shall be selected.
55. It shall be allowed to dry only one strain of the microorganism in the apparatus at a time.
56. Reactivation of microorganism strains with subsequent inoculating of a lyophilized strain from an ampoule shall be carried out as follows:
1) the sealed end of the ampoule is pretreated with alcohol using a cotton swab and heated over the burner flame;
2) to form a crack, a sterile cotton swab (cotton plug) moistened with sterile water is applied to the heated end;
3) with tweezers, a scalpel (or other suitable instruments), the end of the ampoule breaks off along the crack, observing sterility;
4) a cotton swab inside the ampoule (if any) is removed with tweezers;
5) using a pipette, sterile water (saline) is inserted into the ampoule;
6) after twenty minutes of reactivation at room temperature, the suspension may be used to inoculate the culture medium.
57. Cryopreservation of bacterial samples shall be used for long-term storage of microorganism strains.
Chapter 6. Procedure for amending the documentation of a deposited microorganism strain
58. The depositor shall make additions to the scientific description and (or) taxonomic definition of the microorganism strain. Any addition shall be made in the form of a written message in any form.
Chapter 7. Procedure for inventory and write-off of a microorganism strain
59. The organization, once every 5 (five) years, shall consider the issue of the value of a microorganism strain for its further storage, including storage of deposited microorganism strains in the National Collection.
60. The inventory procedure shall include the identification of all available microorganism strains.
61. If the organization decides to write off the strain of the microorganism, the department shall be notified in advance in writing, and subsequently, an information letter is sent to the depositor indicating the reason and date of its implementation.
Application for depositing a microorganism strain
The depositor ______________________________________________________
hereby request to deposit the microorganism strain from ____________________
____________________________________________________________________.
1. Individual identification number/Business identification number
_____________________________________________________________________
2. Address of the place of residence and registration/Address of location (legal address):
________________________________________________________________________
(zip code, city (region), district, street, house (office) number)
3. Contact phones (fax number): ______________________________________
4. The following documents are attached to the application:
_________________________________________________________________
________________________________________________________________
The head of the depositor:
______________________________________________________ __________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
| Annex 2 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
Application for the deposit of a microorganism
The depositor _________________________________________________________
applies for the deposit of the microorganism for registration and storage with the
subsequent filing of an application for an invention in the Republic of Kazakhstan.
1. Name of the microorganism ______________________________________
2. Cultivation conditions ___________________________________________
3. Preservation conditions __________________________________________
4. Storage conditions _____________________________________________
5. Reactivation conditions ___________________________________________
6. Conditions for the viability test _________________________________
7. Components of the consortium (if applicable) ______________________
Description of components ___________________________________________
________________________________________________________________
8. Method of checking the presence of components in a consortium of microorganisms
_____________________________________________________________________
9. Scientific description and/or taxonomic definition of the microorganism
____________________________________________________________________
____________________________________________________________________
10. Certificate of the results of testing the culture or consortium for pathogenicity and/or
indication of properties that pose a threat to the environment
___________________________________________________________________
____________________________________________________________________
Head of the depositor:
_________________________________________________ __________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
Passport of the strain of the microorganism transferred for deposition
1. Nomenclature data:
Collection number | ||
Genus | Type | Subspecies, variant |
The number assigned by the depositor | Synonyms: | |
Accepted: | Date of receiving: | |
2. Origin: excreted from or externally:
Separated from _____________________________ | Parent strain(s), identification link, location (collection) | ||
Location of sampling site for separation | |||
Separation method (environment and conditions) | |||
Separated by | Method of creation (environment, mutagen, exposure conditions) | ||
Identified by (bibliographic link to the identifier) | |||
Compared with type strain (collection number) | |||
Description of the species is given in the book: | |||
Identified by | date | Created by | date |
3. Biotechnological characteristics:
The name of the produced substance, property, or other purposes of the strain that served as the basis for filing an application for an invention | |
The composition of the medium and the cultivation conditions that ensure the maximum level of beneficial properties: | Product yield, activity level, productivity: |
Method of determination (testing): | |
Other features: | |
Morphological and cultural properties
4. Vegetative cells:
Environment, temperature, age, growth conditions | ||
Shape, color, dimensions | Outlines of the ends | Gram stain |
Acid resistance | Cell wall type | Breeding type |
Divergence type during division, cell aggregates | Mobility (type, nature of flagellation) | Organelles, inclusions, vacuoles |
Buds, prostheses, drank, appendages | Capsule, covers | Ultrastructure features |
5. Formation of specialized cells (spores, cysts):
Environment, temperature, age, inducing conditions | ||
Cell type(s) |
The nature of formation | Cell shape |
Number and location of cells | Shape, size of cells | Cell type and conditions |
Other features: | ||
6. Characteristics of colonies on dense medium:
Environment, temperature, age, | Size | Shape, profile, edge, mobility |
Consistency and surface | Surface color, backside, fluorescence, transparency, the release of pigments into the medium |
7. Growth in a liquid medium
Environment temperature, age, growth conditions | Growth pattern (film, ring, sediment, turbidity, growth along the tube wall) |
Changes in the environment (coloration, fluorescence, odor, pH change, precipitation) | Other features |
Physiology - biochemical properties
8. Belonging to the trophic group: photoautotrophs, photo heterotrophs, chemoautotrophs, chemo heterotrophs; definition conditions:
9. Donors (D) and acceptors (A) of electrons in the photo- and chemosynthesis:
10. Types of catabolism: respiration, anaerobic respiration, fermentation; terms:
11. Symbiotrophic relationships (predation, parasitism), partners, conditions:
12. Attitude to:
Oxygen (aerobic, microaerophilic, aerotolerant, or severe anaerobic) | |||
Light (spectrum, intensity) | Temperature (maximum, minimum, optimum) | Hydrogen index (maximum, minimum, optimal) | Antibacterial agents (concentration) |
Phage | Osmo- and halotolerance | Other factors | |
13. Other characteristic physiological features of metabolism:
Differentiating and diagnostic enzymes | Impact on diagnostic substrates (gelatin, starch, esculin) | |
Typical fermentation products | Formation of hydrogen sulfide, indole | Other features |
14. Marker signs of the strain and methods for their detection:
Genetic (special mutations) | Physiological (auxotrophy) |
Biochemical | Immunochemical |
15. Geno- and chemo-taxonomic characteristics:
Hybridization of deoxyribonucleic acid with deoxyribonucleic acid of reference strains | Genome size, presence, and characteristics of plasmids |
differentiating components of the cell wall: | |
differentiating features of lipid composition, mycolic acids: | |
differentiating antigens: | |
other features: spectra of proteins, cytochromes, quinones | |
16. Information on the presence of pathogenic properties:
17. Information about depositors:
No. | Surname, name, patronymic (if any) of the depositor(s) | Position | Signature | Date | Name, address, and telephone |
1 |
Passport of the virus strain transferred for deposit
1. The name of the virus and strain (accepted international terminology), symbol, or number
____________________________________________________________
2. Where, by whom, when, and from what species of animals the virus was isolated ____________
__________________________________________________________________________
3. From which institution the strain was obtained, date of receipt ________________________
__________________________________________________________________________
4. Characteristics of the strain (epizootic, vaccine, industrial, museum, laboratory) and its intended purpose
__________________________________________________________________________
9. Hemagglutinating properties (titer) ______________________________________
__________________________________________________________________________
10. Serological characteristics (antigenic properties) of the strain:
Compliment binding reaction _____________________________________________
Diffuse precipitation reaction ____________________________________________
Hemagglutination delay reaction ___________________________________________
Hydrogen index (hereinafter referred to as pH) __________________________________
tic strain (epizootic, vaccine, industrial, museum, laboratory) and its intended purpose
___________________________________
5. Where (in which institution) is the duplicate strain stored __________________________
__________________________________________________________________________
6. Basic properties characterizing the strain (taxonomy): the species to which the virus strain is assigned
___________________________________________________________________
7. Prevailing tropism (epitheliotropy, neutrotropicity) ________________________
_________________________________________________________________________
8. Susceptible animals (naturally susceptible and laboratory), methods of infection, and incubation period
_______________________________________________________________________
11. Immunogenicity of the strain ____________________________________________
12. The titer of the virus strain (indicate the biological system on which it is determined) ___
__________________________________________________________________________
13. The ability of the virus to spread in vivo ______________
14. Basic storage conditions of the strain:
Storage temperature ______________________________________________________
Composition of the medium and stabilizer _____________________________________
pH of the medium _________________________________________________________
Permissible storage time without "refreshing" ___________________________________
15. Type of closure __________________________________________________________
16. Maintaining and "refreshing" the strain:
Cell cultures (type of cells) _____________________________________________
Developing bird embryos ________________________________________________
Laboratory or farm animals ________________________________________________
Frequency and time of the last refreshing ________________________________
17. Stability of the main properties of the strain during long-term storage and maintenance:
Saving title __________________________________________________________
Titer activity __________________________________________________________
Preservation of immunogenicity ______________________________________________
Stability of the genetic properties of the virus _____________________________________
In what form and quantity the strain is issued (sent). Recommendations for transportation and "freshening"
_____________________________________________________________________
Additional information about the strain (bacterial sterility; absence of foreign pathogenic viruses contaminants)
__________________________________________________________________________
20. To whom is the strain issued (where it is sent) __________________________________
21. Basis for issue or forwarding (whose permission or order, number, date) ___________________________________________________________________________
22. Date of issue (departure) _______________________________________________
No. | Surname, name, patronymic (if any) of the depositor (s) | Position | Signature | date | Name, address, and telephone |
1 |
| Attachment to the passport of the virus transmitted for deposit |
Storage card
Collection number ______________________________________________________
Preservation and storage of the strain storage on a nutrient medium:
Pre-Cultivation | Storage | Source of information | |||
Environment, aeration, inoculation method (streak, prick), age (growth phase), conditions inducing the formation of spores of resting cells | Storage temperature | Recommended timing of reseeding | Maximum pot life | Changing properties during storage | |
Storage under mineral oil:
Pre-Cultivation | Storage | Source of information | |||
Environment, aeration, inoculation method (streak, prick), age (growth phase), conditions inducing the formation of spores of resting cells | Storage temperature | Recommended timing of reseeding | Maximum pot life | Changing properties during storage | |
Storage in water or aqueous solutions:
Pre-cultivation | Storage | Source of information | ||||
Environment, aeration, inoculation method (streak, prick or), age (growth phase), conditions inducing the formation of spores of resting cells | Water (solution) | Storage temperature | Recommended timing of reseeding | Maximum pot life | Changing properties during storage | |
Freeze-dried (l-dried) storage:
Pre-cultivation | Lyophilization (L-drying) | Storage temperature | ||||
Environment, temperature, aeration, age (growth phase), conditions inducing the formation of spores of resting cells | Protective environment | Cell concentration | Calibration time and temperature | Lyophilization mode (L-drying) | Residual moisture | |
Storage at low (from minus 20 degrees Celsius to 90 degrees Celsius) and ultra-low temperatures (in liquid nitrogen and its vapors):
Pre-cultivation | Conservation | Storage | ||||
Environment, temperature, aeration, age (growth phase), conditions inducing spore formation | Preservation material: suspension agar blocks | Cryoprotectant | Cell concentration | Equilibration time and temperature | Conservation mode | |
| Annex 5 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
Deposit certificate
No. ___________ " " 20___
Depositor____________________________________________________________
(for an individual - last name, first name, patronymic (if any),
place of residence; for a legal entity - name, location (legal address))
1. Name of the microorganism ____________________________________________
_____________________________________________________________________
(name, collection-number)
2. Scientific description and/or taxonomic definition of a microorganism family:
____________________________________________________________________
gender: _________________________________________________________________
type:________________________________________________________________
The microorganism named in paragraph 1 was accompanied by a request for deposit, including:
passport
3. Receipt and acceptance It is hereby stated that the microorganism named in paragraph 1 has been deposited for storage
4. Date of deposit ___________________________________________
5. Organization _________________________________________________
Head of the laboratory:
_____________________________________________________ __________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
Passport of the collection strain of the microorganism
Strain number: ______________________________________________________
Deposit date: _______________________________________________________
1. Species name of the sample: _________________________________________
2. Number and name of the strain: ______________________________________
3. By whom, when and from what species of animal the strain was isolated: ________________________
4. Who (surname, name, patronymic (if any)), where (organization and its address) and when identified this strain:
__________________________________________________
5. Bibliographic reference to the identifier: _______________________________
6. Cultural, morphological and biochemical characteristics of the __________ strain
7. Serological properties: _____________________________________________
8. Biological properties in laboratory animals (pathogenicity) ______________
9. Scope of the strain: ______________________________________________
10. Method, conditions and composition of media for long-term storage of the strain: ______________
11. Method, conditions and composition of media for the propagation of the strain: ________________
12. Conditions and composition of the fermentation medium: ________________________
13. Genetic characteristics of the strain (resistance to antibiotics, phages) _______________
__________________________________________________________________________
14. Is the strain (yes, no): zoopathogenic? phytopathogenic? - is it dangerous for other reasons? if yes, explain:
15. Reasons for deposit:
a) for the purpose of storage and delivery of samples: ______________________________
b) for the purpose of filing an application for an invention: ___________________________
16. The author requests to be informed about requests for the strain (yes, no): __________________
17. Information about the strain is included in the collection catalog prior to obtaining a patent (yes, no):
________________________________________________________________________
18. The author is informed that the strain will be investigated and included in the National Collection of Deposited Microorganism Strains, _______ culture samples will be distributed in accordance with the current regulatory legal acts, covering the collection costs (yes, no): _________________________
The authors restore the strain in the National Collection of deposited microorganism strains in case of loss of their viability.
The author will inform in writing about the receipt of the patent before the expiration of 3 (three) years from the date of deposit.
19. Depositor details: _____________________________________________________
The name of the organization where the strain was obtained: _____________________
Author or group of authors: ________________________________________________
Address, fax, telephone of the depositor: _____________________________________
20. Information about the patent holder:
Filed application _________ No. __________ dated _________
Patent _______________ No. __________ dated _________
Addressee and his coordinates: _________________________
Head of the laboratory:
______________________________________________________ __________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
| Annex 7 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
Information card
Nomenclature data:
Genus | Type, subspecies (option) | Type |
Author(s) and year of description | ||
Collection number in the World Directory of Crop Collections | Acronym for collection | The strain number assigned by the collection |
Synonyms: | ||
History:
Accepted as (genus) | Type, subspecies (option) | Date Accepted day/month/year |
Accepted (person or collection, their address) | Strain designation | |
Accepted (person or collection, their address) | Strain designation | |
Accepted (person or collection, their address) | Strain designation | |
Any additional information on the history of the strain | ||
Availability in other collections | ||
Origin:
Isolated from (if from a plant, animal or protozoan, give their generic and specific name, as well as the trivial name of the host) | Anatomical part (if possible) | |
Location | ||
Republic or region, state or province | Nearest settlement | Distance and direction from city (area) |
Height above sea level | Latitude (North or South) | Longitude (East or West) |
Separated by | Strain designation | Date day/month/year |
Identified by: | Date day/month/year | |
Maintaining:
Special properties, application (for example typical strain, citric acid producer):
Links (author, journal, volume, page, year):
1. |
2. |
3. |
Application for re-deposition of a microorganism strain
The depositor ________________________________________________
confirms that the newly deposited microorganism is the same as the one deposited initially and requests to re-deposit the microorganism strain
__________________________________.
1. Reason for re-deposit (underline as required):
1) the initially deposited microorganism is not viable
2) other reasons (specify which ones) ________________________
2. Date of receipt of the relevant notification __________________
3. Individual identification number/Business identification number
_______________________________________________________
4. Address at the place of residence and registration/Address of location (legal address):
__________________________________________________
(zip code, city (region), district, street, house (office) number)
5. Contact phones (fax number): ____________________________
6. Latest scientific description and/or taxonomic definition of the microorganism in relation to the initial deposit *
_______________________________________________________
Head of the depositor:
_______________________________________________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
Note:
* the passport of the strain of the microorganism is attached.
| Annex 9 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
Viability certificate of the deposited microorganism
_________________________________________________________________________
(name of organization)
1. Depositor _______________________________________________________________
(name and/or name of the organization, address)
2. Microorganism ___________________________________________________________
(name and registration number assigned by the collection)
3. Date of deposit: ___________________________________________________
4. Date of transfer (if any): ____________________________________________
5. Certificate of viability
It is hereby confirmed that the viability of the microorganism named in paragraph 2 (the above microorganism) has been tested and the said microorganism is:
viable
unviable
4. Conditions under which the viability study was conducted _____________
__________________________________________________________________________
__________________________________________________________________________
5. Organization: ____________________________________________________________
Head of the laboratory:
____________________________________________________ _____________________
(surname, name, patronymic (if any)) (signature)
| Date: " " 20 __ | |
| Annex 10 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
Extract from the passport of the collection strain of the microorganism
_______________________________________________________________
_______________________________________________________________
1. Name of the genus, species, subspecies of the microorganism: __________
2. Strain catalog number: __________________________________________
3. Characteristic of pathogenicity: ___________________________________
4. Source of separation of the strain (substrate, geographical location, date of separation):
_______________________________________________________________
_______________________________________________________________
5. Practical value of the strain: _________________________________
6. Cultivation conditions: _____________________________________
6.1. Composition of culture media ______________________________
6.2. pH of the medium _______________________________________
6.3. Growing temperature and duration __________________________
__________________________________________________________
6.4. The shelf life of the strain with periodic reseeding _____________
7. Form of issue of the strain from the collection __________________
Head of the laboratory
__________________________________________ ___________________________
(surname, name, patronymic (if any)) (signature)
Date: " " 20 __
| Annex 11 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| The form |
The act of transferring microorganism strains outside the organization
dated __________ 20___ No. ___
We, the undersigned, ___________________________________________________
_____________________________________________________________________
(position, surname, name, patronymic (if any) of the transmitting microorganism, place of transmission)
__________________________________________________________________________
(position, surname, name, patronymic (if any), receiving, name of the organization)
compiled this act stating that, according to the order of the head of the organization
__________________________________________________________________________
transfer of the microorganism
__________________________________________________________________________
__________________________________________________________________________
(species name, strain number, number of objects, type of packaging)
Date of transfer ________________________________________________________
Submitted by: __________________________________________ _______________
(surname, name, patronymic (if any)) (signature)
Accepted by: __________________________________________ ________________
(surname, name, patronymic (if any)) (signature)
The act of transfer of microorganism strains within the laboratory (organization) dated __________ 20 ___ No. _____
We, the undersigned, __________________________________________________
__________________________________________________________________________
(position, last name, first name, patronymic (if any) of the transmitting pathogenic microorganism, place of transmission)
__________________________________________________________________________
(position, last name, first name, patronymic (if any) of the pathogenic microorganism)
compiled this act in that, according to the order the head of the laboratory (department) _________________________________________________
__________________ the pathogenic microorganism was transferred: __________________ _____________________________________________
(species name, strain number, number of objects, type of packaging) __________________
__________________________________________________________________________
Date of transfer ___________________________________________________________
Transferred by: ___________________ __________________________ _______________
(last name, first name, patronymic (if any)) (signature)
Accepted by: ________________________________________ _____________________
(last name, first name, patronymic (if any)) (signature)
The act of transfer of microorganisms for (after) temporary storage
dated __________ 20 ___ No.
We, the undersigned, __________________________________________________
__________________________________________________________________________
(position, surname, name, patronymic (if any) of the transmitting, receiving the microorganism, place of transfer)
compiled this act in that, according to the order of the head of the laboratory (department)
__________________________________________________________________________
____________________, the microorganism was transferred:
__________________________________________________________________________
(species name, strain number, number of objects, transfer conditions: with or without the right to reseeding)
Packaged in ___________________________________________________________
The specified microorganisms are in __________________________________________
(number of the room, safe, and refrigerator) Simultaneously transferred to
________________________________________________________
(name of accounting documentation, key to the safe)
Date of transfer ________________________________________________________
Transferred by: __________________________________________ ______________
(last name, first name, patronymic (if any)) (signature)
Accepted by:
_____________________________________________ _______________________
(surname, name, patronymic (if any)) (signature)
The act of opening a container with microorganisms to inoculate or destruction
from __________ 20 ___ No.
We, the undersigned, ___________________________________________________
_____________________________________________________________________
(position, last name, first name, patronymic (if any)) __________________________
according to the permission of ____________________________________________
(position, last name, first name, patronymic (if any), who gave permission)
_____________________________________________________________________
(number and date of permission) opened the container (s) with a microorganism
____________________________________________
(name of container, name of species, _______________________________________
strain number, number of objects)
for the purpose of __________________________________________________________
(inoculating a microorganism or its destruction)
The container(s) with the remnants of the pathogenic microorganism was (were) disinfected ______________
________________ by autoclaving _________________________ or immersion (date) (autoclaving mode)
in_____________________________________________________________________
(name of the disinfectant solution, its concentration, disinfection time)
Date of opening the container(s) _____________________________________________
The act of destruction of a strain of microorganisms
dated __________ 20 ___ No. ___
We, the undersigned, ________________________________________________________
__________________________________________________________________________
(position, last name, first name, patronymic (if any))
_____________________________________________________________________
according to the permission of ____________________________________________
(position, last name, first name, patronymic (if any)), who gave permission)
_____________________________________________________________________
(number and date of permission) destroyed microorganism _______________________________________________________ _______________________________________________________________________________________________________
(species name, strain number, number of objects) _________________________________________________________________________
by autoclaving __________________________________________ or immersion (autoclaving mode) in
_____________________________________________ ____________________________
(name of the disinfectant solution, its concentration, disinfection time)
Date of destruction of the microorganism ______________________________________
(signatures)
| Annex 16 to the Rules for depositing microorganism strains, maintaining the National collection of deposited microorganism strains |
|
| microorganisms | |
| The form |
Test report
dated "___" _____________ 20__ to "___" _____________ 20__
The purpose of the experiment _______________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Materials and equipment ____________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Research methods _________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Research results ___________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Conclusion ________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
Performers: __________________________________________ _____________________
(surname, name, patronymic (if any)) (signature)
Date: "_____" 20____
