Voluntary Report - Public distribution

**Date:** 11/2/2007

**GAIN Report Number:** RS7078

RS7078

**Russian Federation**

**Biotechnology**

**Registration Procedure for GMO Feeds**

**2007**

**Approved by:**

![](media/image1.wmf)Kimberly Svec

U.S. Embassy

**Prepared by:**

Yelena Vassilieva, Kimberly Svec, and Mikael Pyrtel

**Report Highlights:**

This report provides an unofficial translation of the procedure to
register feeds produced from genetically modified organisms (GMOs). In
accordance with the resolution of the Russian Government that
transferred the testing and registration of biotechnology feeds from the
Ministry Of Agriculture to the Federal Service for Veterinary and
Phytosanitary Surveillance (VPSS), VPSS developed the administrative
statute (procedure) for registration. The draft was posted on the
Ministry of Agriculture's website for comments and discussion at the end
of August 2007. Sources report that VPSS has already accepted
applications based on the procedures described in the draft.

Includes PSD Changes: No

Includes Trade Matrix: No

Trade Report

Moscow \[RS1\]

\[RS\]

In July 2006, the Federal Service for Veterinary and Phytosanitary
Surveillance (VPSS) assumed the responsibilities for testing and
registration of biotechnology feeds from the Russian Ministry of
Agriculture[^1]. Following the transfer, the Ministry of Agriculture and
VPSS developed an internal document on the procedures for registering
biotechnology feeds, and offered the draft for public discussions and
comments.  The process to develop a draft that complies with Russian
legislative standards took almost a year, although experts report that
the draft procedure is similar to what the Ministry of Agriculture had
before the transfer of duties.  This draft was posted on the Russian
Ministry of Agriculture website at the end of August for comments and
discussion[^2].  Sources believe the draft will be signed by the
Minister of Agriculture without any changes or additions. Moreover, VPSS
has already started to accept registration applications for
biotechnology events and feeds, and the actual procedure is exactly the
same as described in the draft. Every individual contract that the
applicant concludes with VPSS contains the description of this
procedure.

The unofficial translation of the draft procedure of registration of
biotechnology feeds follows.

##### Draft

##### Approved by the Order 

##### of the Ministry of Agriculture

###### of the Russian Federation

« » 200\_ №

##### administrative STATUTE 

of the federal service for veterinary and phytosanitary surveillance to
fulfill the state function to register the feeds manufactured from
genetically engineered modified organisms

**1. General provisions**

1.  The Administrative Statute covering the fulfillment of the state
    registration of feeds (hereinafter referred to as the Statute)[^3]
    manufactured from genetically modified organisms (hereinafter
    referred to as the GMO), created by the Federal Service for
    Veterinary and Phytosanitary Surveillance[^4], determines
    Rosslkhoznadzor's timeframes and administrative procedures for
    federal registration of feed manufactured from GMOs and issuing
    certificates for federal registration.

Registration of GMO feeds will comply with the following legislative
acts:

A.  Federal Law No. 86-F3 "On The State Regulating In The Area Of
    Genetic Engineering Activity" July 5^th^, 1996[^5].

B.  Federal Law No. 184-FЗ "On technical regulation" of December 27,
    2002

C.  Statutory Document "On the Federal Service For Veterinary and
    Phytosanitary Surveillance" approved by Resolution No. 327 of the
    Russian Government on June 30, 2004.

D.  Russian Government Resolution No. 26 approved January 18, 2002, "On
    the state Registration of the Feeds Manufactured from Genetically
    Engineered Modified Organisms".[^6]

E.  Statutory Document "On the State Registration of the Genetically
    Engineered Modified Organisms", approved by Russian Government
    Resolution No. 120 on February 16, 2001.

1.2. Rosselkhoznadzor will establish an Expert Board (advisory
committee) to evaluate materials submitted for federal registration of
feeds and input materials (raw materials) manufactured from GMOs
(hereinafter referred to as the Expert Board). The Expert Board will
ensure objectivity and consistent quality when reviewing safety data
about GMO feeds submitted by applicants. The composition of the Expert
Board must be approved by the Head of the Rosselkhoznadzor.

1.3. Certificates for GMO feeds will be issued for five-year terms with
an option to recertify for an additional five years.

1.4. The Russian Ministry of Agriculture will maintain the state
registry of approved GMO feeds[^7].

1.5. Russian Federation law authorizes Rosselkhoznadzor to reverse
(annul) the certification of registered GMO feeds followed by the
appropriate entry in the state registry[^8].

1.6. The address to submit documentation and applications is as follows:

> Orlikov per., 1/11, Moscow, 107139, Rosselkhoznadzor[^9].
>
> The telephones for preliminary appointments and inquiries are as
> follows:
>
> \(495\) 207-07-41;

Zvenigorodskoye Schosse, 5, Moscow, 123022, FGU (VGNKI)[^10].

The telephone number for preliminary appointments and inquiries is as
follows:

\(495\) 253-14-73.

1.8. Applicants are prohibited from registering different types of GMO
feeds or input materials (raw materials) under the same name (title).

1.9. Applicants are prohibited from registering the same GMO feed
multiple times under the same name (title) or different names (titles).

**2. Administrative Procedures**

2.1. Rosselkhoznadzor, or its subsidiary federal state establishment,
the All-Russian Center for Quality and Standardization of Veterinary
Pharmaceuticals and Feeds[^11] (hereinafter referred to as -- FGU
«VGNKI») carries out the federal registration of GMO feeds by:

> а) Accepting, recording, and considering registration applications for
> GMO feeds and the materials attached to the application;
>
> b\) Issuing registration certificates for GMO feeds, and authorizing
> its delivery into the territory of the Russian Federation.

2.2. The certification process for previously unregistered GMO feed(s)
may require two additional years due to additional testing required for
biological safety.

2.3. The administrative procedures, including the procedures to obtain
GMO certification, and the timeframes to conduct the certification, are
listed in Attachment 1.

2.4. Acceptance and consideration of the application and materials to
federally register GMO feeds or the input materials (raw materials)
manufactured from the GMO is carried out as follows:

The legal entity or the physical entity that produces or imports the
feeds (hereinafter referred to as -- the Applicant) will submit the
following to the FGU (VGNKI):

a)  An application for federal registration of the GMO feed(the
    application form is listed in Attachment 2);

b)  Materials containing the following:

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i.  Data regarding the origin of the GMO feed

ii. Evaluation of the potential dangers resulting from the use of GMO
    feeds (compared to the original basic feed or input material) and
    applicant's recommendations to decrease the danger;

iii. Data on the end use of GMO feed and data on the registration and
     the use of the feed in question abroad;

iv. Data on the technology used to grow the variety of the modified
    plant used to manufacture the feed;

v.  Data on the technology used to manufacture the GMO feed, including a
    draft instruction for use of the GMO feed.

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c)  In circumstances where the plant variety used to manufacture feed is
    able to reproduce itself, and is intended for subsequent growth of
    bio-mass and fodder grain, the applicant will submit a copy of the
    registration certificate of the modified plant to the Federal
    Register of Selection Achievements Allowed for Cultivation;

d)  The power of attorney from the company producing the feed;

e)  In circumstances where the applicant commissioned an evaluation or
    assessment of the GMO feed from relevant experts, the results of the
    evaluation may be submitted as part of the application package for
    GMO registration.

2.5. All documents to register GMO feed will be submitted in the Russian
language, or must have a certified Russian translation. The applicant is
responsible for the authenticity of the data listed in the application
and the materials attached to the application.

2.6. The FGU (VGNKI's) division responsible for registering GMO feeds
will verify completeness and authenticity of the submitted data within
three days of receipt to determine the following:

a)  The applicant submitted all mandatory documents as per paragraph
    2.4;

b)  The consistency of the information submitted in the application;

c)  Document authenticity; confirmed by the signature of the head of the
    organization on every document.

2.7. Within three days of receipt, the FGU (VGNKI) will forward the
registration application and the draft of the instruction to use the GMO
feed to Rosselkhoznadzor,. The application can be rejected in the
following cases:

a)  The set of the documents is not complete;

b)  The documents submitted are not consistent;

c)  The registration application and/or the draft of the instruction to
    use the GMO feed have not been developed in accordance with the
    forms (Attachments 1 and 2 to this Statute);

d)  The documents' copies have not been certified adequately resulting
    in the impossibility to confirm the authenticity of the documents
    submitted;

e)  The certified translation of the documents submitted into the
    Russian language is not available;

f)  The power of attorney from the company producing the feed is not
    available or is not valid.

2.8. If the GMO feed application is accepted, then the application will
be registered in the Rosselkhoznadzor with a file number assigned to the
application. The department head will appoint a "responsible performer"
(hereafter referred to as responsible performer) charged with reviewing
the application and the draft of the instruction to use the GMO feed.
The applicant has the right to request the surname, name, patronymic and
the office telephone of the responsible performer. The applicant may
request this information verbally or in writing.

2.9. The responsible performer will develop a registration packet
containing the application and the draft instruction on feed usage, in
addition to other relevant documents or materials. The draft instruction
is replaced by the approved instruction, upon registration of the GMO
feed, and the case is archived with Rosselkhoznadzor.

2.9.1. If the application is rejected, then the registration process is
suspended, and Rosselkhoznadzor will notify the applicant in writing and
request missing documents, or recommend amendments to the applicant's
existing documents. The registration is denied if the applicant fails to
respond within 30 days of receiving the notification.

**3. Expert Board Procedures**

3.1. Within 14 days of receipt of the completed application, the
responsible performer will compile a list of feed applications and
submit the list to the Expert Board.

The Expert Board will meet as required to review GMO feed applications,
but not less than once every quarter.

3.2. Within 30 days the Expert Board will review the safety data
submitted by the applicant and the manufacturing methods used in
creating the GMOs. If the data is not sufficient, the Expert Board will
request additional safety information or recommend to the applicant
additional testing at an accredited testing facility.

3.3. If the applicant fails to present additional safety information
within three months of notification from the Expert Board, the FGU
(VGNKI) will notify the applicant in writing that the Expert Board is
unable to conclusively judge the safety of the GMO feed. A copy of this
notification is added the applicants file at the Rosselkhoznadzor.

3.4. Recommendations to approve or suspend the application are based
upon the application packet, including the testing protocols, submitted
by the applicant. The Expert Board may not recommend approval if there
is scientifically substantiated data that the GMO feed threatens the
lives or health of animals.

3.5. Recommendations to approve the registration are forwarded to
Rosselkhoznadzor within ten days of the Expert Board's decision. The
recommendations are communicated through an official letter signed by
the Chairman of the Expert Board. A list of GMO feeds recommended for
registration (with instructions on their use) will accompany the
official letter, in addition to and notifications of registration
suspensions, with reasons for the suspensions.

**4. Registration and Issuance of the Registration Certificate**

4.1. Rosselkhoznadzor will decide to approve or reject the applicant's
registration within 20 days of receiving the Expert Board's
recommendations. If registration is approved, Rosselkhoznadzor assigns a
file number to the registration and forwards the information to the FGU
(VGNKI). FGU will assign a registration number to the GMO feed and issue
the registration certificates within ten days of receiving the approval
from Rosselkhoznadzor. The registration certificate will be forwarded to
Rosselkhoznadzor for final signatures from the head of Rosselkhoznadzor,
or an official acting on his/her behalf. After the signatures, the
responsible performer will inform the applicant that the federal
registration passed and is available at Rosselkhoznadzor

4.2. The responsible performer will forward the information about the
federal registration to the Ministry of Agriculture of the Russian
Federation for entry into the State Registry of GMO Feed (hereinafter
referred to as -- the Registry).

4.3. If Rosselkhoznadzor rejects the registration, then the applicant is
notified in writing within five days of Rosselkhoznadzor's decision with
details specifying reasons the registration was not approved.

**5. Extending the Validity of the Federal Registration Certificate**

5.1. Within three months of the expiration date of the original
certificate, the owner must submit an application to Rosselkhoznadzor
requesting an extension of the registration to prevent the certificate
from expiring. The re-registration procedure is similar to the original
registration

**6. Annulment of the Federal Registration Certificate**

6.1. Certificates can be annulled if either or both of the following
conditions are satisfied:

a)  First, if animal health officials discover a relationship between
    GMO feed usage and deterioration in animal health.

b)  Second, the adulteration of the GMO feed by modified organisms not
    registered in the Russian Federation.

> If these conditions are satisfied, then the GMO feed is required to be
> withdrawn from handling followed by the appropriate entry in the
> Registry. Rosselkhoznadzor will notify the relevant federal executive
> authorities within 15 days of the date the decision was made to annul
> the certificate.

6.2. Refusal to administer federal registration procedures for
certifying GMO feed, as well as annulments of the certificate of GMO
feed registration, may be appealed in court.

**7. The Appeals Process**

7.1. If a Russian Federation citizen disagrees with a decision reached
by Rosselkhoznadzor, or its territorial bodies, then they have the right
to appeal to the higher level official (or organization) and/or to the
courts. The appeal must be filed within the time allowed by law, and
follow pre-court and court procedures. The Ministry of Agriculture of
the Russian Federation controls the activities of Rosselkhoznadzo.
Rosselkhoznadzor controls the activities of its territorial bodies.

7.2. Appeals may be filed based on the following circumstances:

a)  Appeals based on decisions reached by the territorial bodies of the
    Rosselkhoznadzor may be filed with the Rosselkhoznadzor;

b)  Appeals based on decisions reached by the Rosselkhoznadzor may be
    filed with the head of the Rosselkhoznadzor;

c)  Appeals based on decisions reached by the head of the
    Rosselkhoznadzor may be filed with the Ministry of Agriculture of
    the Russian Federation. Including if the head of Rosselkhoznadzor
    does not take actions guaranteed by Russian law relating to the
    action (or inaction) of Rosselkhoznadzor's officials or its
    territorial bodies.

7.3. Applicants have the right to submit appeals verbally, or send
written appeals to local or regional government bodies, and federal
officials.

7.4. Applicants will exercise their right to appeal freely and
voluntarily, and appeals are carried out free of charge. The freedoms of
other persons will not be violated by the citizens exercising their
right to appeal.

7.5. The head of Rosselkhoznadzor and heads of its territorial bodies
will set up appointments with individual citizens. The time and location
of these appointments will be published for the public.

7.6. Applicants will present the documents identifying themselves when
coming to an individual appointment. Citizens may submit oral or written
testimony during the appeals process. Oral testimony will become part of
the appointment record. Written testimony must be registered and follow
the procedures established for written appeals. After reviewing the
appeal, if a conclusion is reached that does not require additional
investigation, then the applicant will receive a verbal reply (with
their consent) during the individual appointment. In such a case, an
appropriate note is made in the individual person's appointment card. In
the remaining cases the reply is given in writing.

7.7. If the appeal contains questions requiring a decision not within
the competence of Rosselkhoznadzor, its territorial body or the
official, then the applicant will receive instructions on the
appropriate procedures to follow.

7.8. The applicant may be refused an appeal, during the individual
appointment, if he/she previously received a reply relating to the
issues in their appeal. The applicants have the right to send a written
proposal, statement, or complaint (hereinafter referred to as -- written
statement) in response to the refusal of an appeal. The term to consider
the written statement will not exceed 30 days from the moment it is
registered.

7.9. In exceptional circumstances the head of Rosselkhoznadzor, or the
head of a territorial body, has the right to extend the term to consider
the appeal for not more than 30 calendar days. The applicant must be
notified about extending the term to consider his/her appeal. These
circumstances may include:

a)  A decision to verify information submitted during testimony, or
    request additional documentation and materials from the appropriate
    territorial body.

b)  Requesting information from other governmental bodies, the bodies of
    local government, or to other officials requesting necessary
    documents and materials to consider the appeal.

7.10. Russian Federation legislation details procedures to extend the
term to consider appeals. In his/her written statement, the applicant is
required to indicate the governing body where the written statement was
sent, or the surname, name, patronymic of the appropriate official, or
the position of the appropriate official. The applicant must also
indicate his/her surname, name, patronymic (the latter -- if available),
the full title (name) of the legal entity, and the mailing address where
the reply is to be sent. If the applicant's return addresses changes,
then the applicant must notify the officials of the new return address.
The applicant must spell out the nature of the proposal, the statement,
or the complaint, and include the date and their signature.

7.11. Additionally the written statement may contain the following:

a)  The title, surname, name and patronymic name of the specialist whose
    action (inaction) constitutes the subject of the appeal (if such
    information is available);

b)  The nature (circumstances) of the action (inaction) that constitutes
    the subject of the appeal; grounds which the applicant considers to
    be the reasons why his/her rights, freedoms, and legal interests
    have been violated and that obstacles erected to implement the
    above-mentioned, or a certain burden has been illegally placed on
    him/her; as well as other data that the applicant considers
    relevant.

c)  If it is necessary to confirm the reasoning behind the appeal, then
    the applicant may attach documents and materials or their copies to
    the written statement.

7.12. Rosselkhoznadzor's official (or the territorial body of the
Rosselkhoznadzor's) will make a decision to approve or refuse the
applicant's claims after deliberating the applicant's case.

7.13. A written response containing the decision will be delivered to
the applicant. If the written statement does not contain the surname and
mailing address of the applicant, then the appeals court decision will
not be delivered.

**8. Reasons an Applicant's Appeal May Not Be Considered**

8.1. During the appeals process the applicant may not receive a response
under the following circumstances:

a)  Upon receiving a written statement that contains extremely rude or
    obscene expressions, threats to life, health or property of the
    official as well as of the members of his/her family,
    Rosselkhoznadzor or the territorial bodies have the right to
    disregard the statement without responding to the nature of the
    issues, and inform the applicant who sent the address about the
    impermissibility of abusing the legislation.

b)  If the text of the written statement is not legible, then the
    response to the statement is not given and the applicant is informed
    about it; provided his surname and address are legible.

c)  If the written statement of the applicant contains a question that
    was the subject for numerous previous written replies sent to the
    applicant on similar issues, and the present address does not
    contain new proofs or circumstances, then the Head of the
    Rosselkhoznadzor, or the territorial body, has the right to
    terminate correspondence with the applicant. Correspondence can be
    terminated if the statement in question and the previous statements
    were sent to the Rosselkhoznadzor, one of the territorial bodies of
    Rosselkhoznadzor, or to one and the same official. The applicant
    that sent the address will be informed about such a decision.

d)  If the response relating to the nature of the issue cannot be
    developed without disclosing the data that constitute a state
    secret, or other secrets that are protected by federal legislation,
    then the applicant will be informed that federal secrecy legislation
    prohibits a reply to his/her appeal.

8.2. If the reasons preventing the development of a response are
removed, however, then the applicant has the right to send the revised
statement to Rosselkhoznadzor or to its territorial body.

**9. Procedure to File Complaints**

9.1. The statement containing complaints against Rosselkhoznadzor's
decision will be returned to the applicant with explanations on the
procedure to appeal against the particular judgment.

9.2. The applicants have the right to complain about the decisions taken
in the course of implementing the state function, action, or inaction by
officials from the Rosselkhoznadzor in court.

9.3. The applicants can post their opinions about violations of their
rights and legal interests, illegal decisions, action or inaction on the
part of the officials from Rosselkhoznadzor, violations of the
stipulations of the Administrative Statute, non-correct behavior or
violations of the official ethics on the Internet-site, or using
electronic mail of the bodies that exercise the state function.

9.4. Applicants filing a complaint should include the following
information:

a)  The surname, name and patronymic of the citizen (name of the legal
    entity) submitting the complaint, a registered permanent or
    temporary residence;

b)  The name of the body, position, surname, name and patronymic of the
    official (if such information is available), whose decision, action
    (inaction) violates the rights and legal interests of the applicant;

c)  The nature of violation of the rights and legal interests of the
    applicant, of the illegal decision, action (inaction);

d)  The applicant's contact information to inform the applicant about
    the measures taken based on the results of his/her application's
    consideration.

Attachment 1

to the Administrative Statute

**[Consideration of the documents and developing decisions about the
federal registration of the feed manufactured from the
GMO]{.underline}**

+---+---------------------------+------+-----------------+-----------+
| № | Administrative procedure  | Term | Performer       | Notes     |
+---+---------------------------+------+-----------------+-----------+
| 1 | The applicant submits the |      | Applicant       |           |
|   | application and materials |      |                 |           |
+---+---------------------------+------+-----------------+-----------+
| 2 | The data and materials    | 7    | the FGU         |           |
|   | submitted by the          | days | «VGNKI»,        |           |
|   | applicant are accepted    |      |                 |           |
|   | and checked               |      | the             |           |
|   |                           |      | R               |           |
|   |                           |      | osselkhoznadzor |           |
+---+---------------------------+------+-----------------+-----------+
| 3 | Materials and testing     | 30   | Expert board    |           |
|   | protocols are reviewed by | days |                 |           |
|   | the Expert board          |      |                 |           |
+---+---------------------------+------+-----------------+-----------+
| 4 | The registration          | 30   | the             |           |
|   | certificate is registered | days | R               |           |
|   | and issued                |      | osselkhoznadzor |           |
+---+---------------------------+------+-----------------+-----------+
| 5 | Extending the term of     |      | This is         |           |
|   | validity of the           |      | analogous to    |           |
|   | certificate about the     |      | the procedure   |           |
|   | federal registration of   |      | of the federal  |           |
|   | the feed, manufactured    |      | registration    |           |
|   | from the GMO              |      |                 |           |
+---+---------------------------+------+-----------------+-----------+

+---+---------------------------+------+-----------------+-----------+
| № | Administrative procedure  | Term | Performer       | Notes     |
+---+---------------------------+------+-----------------+-----------+
| 1 | The applicant submits the |      | Applicant       |           |
|   | application and materials |      |                 |           |
+---+---------------------------+------+-----------------+-----------+
| 2 | The data and materials    | 7    | the FGU         |           |
|   | submitted by the          | days | «VGNKI»,        |           |
|   | applicant are accepted    |      |                 |           |
|   | and checked               |      | the             |           |
|   |                           |      | R               |           |
|   |                           |      | osselkhoznadzor |           |
+---+---------------------------+------+-----------------+-----------+
| 3 | Materials and testing     | 30   | Expert board    |           |
|   | protocols are reviewed by | days |                 |           |
|   | the Expert board          |      |                 |           |
+---+---------------------------+------+-----------------+-----------+
| 4 | The registration          | 30   | the             |           |
|   | certificate is registered | days | R               |           |
|   | and issued                |      | osselkhoznadzor |           |
+---+---------------------------+------+-----------------+-----------+
| 5 | Extending the term of     |      | This is         |           |
|   | validity of the           |      | analogous to    |           |
|   | certificate about the     |      | the procedure   |           |
|   | federal registration of   |      | of the federal  |           |
|   | the feed, manufactured    |      | registration    |           |
|   | from the GMO              |      |                 |           |
+---+---------------------------+------+-----------------+-----------+

Attachment №2 to the Administrative Statute

APPLICATION

I request registration in the Russian Federation of the feed
manufactured from genetically-engineered-modified organisms,
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

1.  Applicant
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2.  Applicant's address, telephones, fax, telex, INN and other data
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

3.  Applicant's representative
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> ~(surname,\ name,\ patronymic,\ address,\ telephone,\ fax,\ №\ of\ the\ power\ of\ attorney)~

4.  Data on the feed:

    0.  Generally recognized
        name\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

        Trade name

> 4.3.1Data on the genetically-engineered-modified organism

2.  Form

    Feed's purpose/function

    Availability of the patent, its number, its owner

    Availability of the certificate for the trade name/title of the
    feed, number of the certificate \_\_\_

    Feed developer

> ~(address,\ telephone,\ fax)~

7.  Feed manufacturer

> ~(address,\ telephone,\ fax)~
>
> The application is filed:
>
> « »
>
> Applicant's signature (applicant's representative signature)
>
> Stamp (surname, name, patronymic, position occupied)

Attachment № 3

To the Administrative regulation

#### 

APPROVED

Deputy Head

of the Rosselkhoznadzor

E.A. Nepoklonov

«\_\_\_» \_\_\_\_\_\_\_\_ 200 \_\_

#### 

#### 

#### INSTRUCTION

**To use (name/title of the feed)**

**for ( area of the feed's use, for whom),**

**containing genetically-engineered-modified organisms**

**Manufacturer: company, country (in the Russian language)**

**company, country (in the English language)**

1.GENERAL DATA

1.  Feed title/name.

2.  Enumeration of all the components in the feed composition specifying
    genetically-engineered-modified organisms.

3.  Enumeration of the nutritious substances of the feed specifying
    their qualitative composition in a feed's unit (please specify the
    range from ... to).

4.  Stability, possibility and terms and conditions of temperature
    processing.

5.  Form of delivery. Packaging, wrapping, storage terms and conditions,
    transportation terms and conditions and use-by-date.

2\. APPLICATION PROCEDURE

1.  Procedures and terms and conditions to use the feed indicating the
    type, gender and age of the animal group, dosages, etc.

2.  Possible side effects and complications, including the ones relating
    to the genes' modification. Prevention measures and measures to
    decrease the danger.

3.  Contraindications for use.

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2.  PERSONAL PREVENTION MEASURES

[^1]: For more information see GAIN RS6039 New Resolution Transfers GMO
    Feed Registration Duties to VPSS

[^2]: ^?^ http://www.mcx.ru/index.html?he_id=900&doc_id=15400

[^3]: Feeds include the products of plants, animals and micro-biological
    origin as well as their components that are used to feed the
    animals, which contain the nutrients that can be assimilated and
    that do not have a negative effect on the animals' health.

[^4]: Hereinafter referred to as Rosselkhoznadzor. English abbreviation
    of Federal Service for Veterinary and Phytosanitary Surveillance is
    VPSS.

[^5]: Amended on July 12, 2000.

[^6]: Amended by the Resolution of the Government of the Russian
    Federation of July 14, 2006, № 422).

[^7]: Data on the registered GMO feeds is available on the official site
    of the Russian Ministry of Agriculture
    [http://www.mcx.ru](http://www.mcx.ru/), and is updated as needed.

[^8]: Information about Rosselkhoznadzor is posted on the official
    portal of the Russian Federation Ministry of Agriculture
    [http://www.mcx.ru](http://www.mcx.ru/)

[^9]: Address in Russian is: Орликов пер., д. 1/11, Москва, 107139,
    Россельхознадзор

[^10]: Address in Russian is: Звенигородское шоссе д. 5, Москва, 123022,
    ФГУ «ВГНКИ»

[^11]: The Russian name for the center is «Всероссийский государственный
    центр качества и стандартизации лекарственных средств для животных и
    кормов» (ФГУ ВГНКИ)