Required Report - public distribution

**Date:** 7/15/2005

**GAIN Report Number:** RS5054

RS5054

**Russian Federation**

**Biotechnology**

**Annual Agricultural Biotechnology Report**

**2005**

**Approved by:**

![](media/image1.wmf)Allan Mustard

American Embassy, Moscow

**Prepared by:**

Agricultural Office Staff

**Report Highlights:**

Russia\'s agricultural biotechnology policy is in transition, and the
future is not clear. After more than a year of suspension of all
activities in the field of biotechnology regulation, in May 2005 Russia
re-established the Interagency Commission for Genetic Engineering. Two
fundamental technical regulations on biotech plants and foodstuff are in
the process of development to be made federal laws in 2006. At present
Russia does not produce biotechnology crops. Registration of imported
biotech crops for food has restarted, but registration for feeds is
still pending.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Moscow \[RS1\]

\[RS\]

Table of Contents

[**Executive Summary 3**](#executive-summary)

[Biotechnology Trade and Production
3](#biotechnology-trade-and-production)

[Status of Products Approvals 3](#status-of-products-approvals)

[Production and Development 4](#production-and-development)

[Trade 5](#trade)

[Food Aid 5](#food-aid)

[Biotechnology Policy 6](#biotechnology-policy)

[Status of Technical Regulations Concerning Biotechnology.
6](#status-of-technical-regulations-concerning-biotechnology.)

[Present Regulatory Framework for Agricultural Biotechnology
7](#present-regulatory-framework-for-agricultural-biotechnology)

[Responsible Government Ministries and Their Roles
7](#responsible-government-ministries-and-their-roles)

[Policy on Co-existence Between Biotechnology and Non-biotechnology
Crops
9](#policy-on-co-existence-between-biotechnology-and-non-biotechnology-crops)

[Food Labeling 9](#food-labeling)

[Labeling for Feeds 10](#labeling-for-feeds)

[Status of Ratification of Biosafety Protocol
10](#status-of-ratification-of-biosafety-protocol)

[Marketing Issues 10](#marketing-issues)

[Capacity Building and Outreach 11](#capacity-building-and-outreach)

[Reference Materials 12](#reference-materials)

[Decree on Creation of the Interagency Commission for Genetic
Engineering, Guidelines and List of Members of Commission
12](#decree-on-creation-of-the-interagency-commission-for-genetic-engineering-guidelines-and-list-of-members-of-commission)

# Executive Summary

Russia's attitude towards agricultural biotechnology is inconsistent.
Russian President Vladimir Putin listed biotechnology in general as one
of mainstreams of Russian science. The official position of the Russian
Minister of Agriculture is also supportive of scientific innovations and
the benefits that biotechnology can bring to Russian agriculture.
However, only very limited federal financing is available for basic
research in the field of genetic engineering, primarily in the field of
biological means of plant protection. Meantime, both application of
international research in the field of agricultural biotechnology and
use of commercialized GMO crops are lagging far behind the experience of
most of other countries of the world. Opposition to development of
agricultural biotechnology in Russia is driven by several beliefs,
including the official concept of the Ministry of Agriculture of
possible extensive development of "organic" Russian agriculture, based
on the availability of vast expanses of arable land. To this influence
are added fear of technology, the expense of reverting to modern,
intensive crop cultivation requiring massive capital investment and
ongoing high input costs, particularly for agricultural chemicals, and
the concept that genetic modification of crops is an unknown and
unpredictable danger to the health of people, animals and environment.
The last source of opposition is widely supported and financed by
Greenpeace Russia.

Legislative bases for research, testing, study, approval, and
registration of genetically engineered agricultural and food products
were developed by 2003 and several biotech events and crops were
registered for import and use in foods. A smaller number of events and
crops was also registered for import and use in feeds.

Registrations for food and feed use have been separated in Russia, and
have been conducted by different agencies. However administrative and
legislative reforms of the last two years suspended these processes.
This report provides a snapshot of the present status of agricultural
biotechnology production and trade, but the future is not clear. Much
will depend on the two basic technical regulations concerning
agricultural and food biotechnology that are been drafted now, and are
unlikely to be approved until 2006.

# Biotechnology Trade and Production

## Status of Products Approvals

The following crops have been approved and registered in Russia in 1999
-- 2003:

+------------------+---------------+-------------+----------+---------+
| Crop             | Applicant     | Year and    |          |         |
|                  |               | period of   |          |         |
|                  |               | r           |          |         |
|                  |               | egistration |          |         |
+------------------+---------------+-------------+----------+---------+
|                  |               | For Food    | For Feed | Bi      |
|                  |               | Use         | Use      | osafety |
|                  |               |             |          | a       |
|                  |               |             |          | pproval |
+------------------+---------------+-------------+----------+---------+
| Bt potato        | Monsanto      | 2002,       |          | 20      |
|                  |               |             |          | 02-2007 |
| Russet Burbank   |               | ext. 2003 - |          |         |
| NL               |               | 2008        |          |         |
+------------------+---------------+-------------+----------+---------+
| Bt Potato        | Monsanto      | 2002,       |          | 20      |
|                  |               |             |          | 02-2007 |
| Superior NL      |               | ext. 2003 - |          |         |
|                  |               | 2008        |          |         |
+------------------+---------------+-------------+----------+---------+
| Roundup Ready®   | Monsanto      | 2000,       | 2003 -   |         |
| corn             |               |             | 2008     |         |
|                  |               | ext. 2004 - |          |         |
| GA 21            |               | 2009        |          |         |
+------------------+---------------+-------------+----------+---------+
| Bt corn          | Monsanto      | 2000,       | 2003 -   |         |
|                  |               |             | 2008     |         |
| MON 810          |               | ext. 2003 - |          |         |
|                  |               | 2008        |          |         |
+------------------+---------------+-------------+----------+---------+
| Roundup Ready®   | Monsanto      | 2002 --     | 2003 -   |         |
| corn             |               | 2007        | 2008     |         |
|                  |               |             |          |         |
| NK 603           |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Bt corn          | Monsanto      | 2003 - 2008 | 2003 -   |         |
|                  |               |             | 2008     |         |
| MON 863          |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Corn Bt 11       | Syngenta      | 2003 - 2008 |          |         |
|                  | Seeds S.A.    |             |          |         |
| Glyph            |               |             |          |         |
| osate-resistant, |               |             |          |         |
| Insect Resistant |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| LL Corn T25      | Bayer Crop    | 2001 - 2007 | S        |         |
|                  | Science       |             | ubmitted |         |
| Glyp             |               |             | 2004,    |         |
| hosate-resistant |               |             | expected |         |
|                  |               |             | 2005     |         |
+------------------+---------------+-------------+----------+---------+
| Roundup Ready®   | Monsanto      | 1999,       | 2003 -   |         |
| soybeans         |               |             | 2008     |         |
|                  |               | ext. 2002 - |          |         |
| 40-3-2           |               | 2007        |          |         |
+------------------+---------------+-------------+----------+---------+
| Liberty Link®    | Bayer Crop    | 2002 - 2007 |          |         |
| Soybeans         | Sciences      |             |          |         |
| A2704-12         |               |             |          |         |
|                  |               |             |          |         |
| Glyp             |               |             |          |         |
| hosate-resistant |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Liberty Link®    | Bayer Crop    | 2002 - 2007 |          |         |
| Soybeans         | Sciences      |             |          |         |
| A5547-127,       |               |             |          |         |
|                  |               |             |          |         |
| Glyp             |               |             |          |         |
| hosate-resistant |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Roundup Ready®   | Mons          | 2001 - 2006 |          |         |
| sugar beet #77   | anto/Syngenta |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Sugar derived    | Mons          | 2001 - 2006 |          |         |
| from Roundup     | anto/Syngenta |             |          |         |
| Ready® sugar     |               |             |          |         |
| beet #77         |               |             |          |         |
+------------------+---------------+-------------+----------+---------+
| Rice LL62,       | Bayer Crop    | 2003 - 2008 |          |         |
|                  | Sciences      |             |          |         |
| Glyp             |               |             |          |         |
| hosate-resistant |               |             |          |         |
+------------------+---------------+-------------+----------+---------+

Applications waiting for approval and expected applications.

+----------------------+---------------+------------+----------------+
| Crop                 | Applicant     | Time of    |                |
|                      |               | submission |                |
|                      |               | for        |                |
|                      |               | approval   |                |
+----------------------+---------------+------------+----------------+
|                      |               | F          | Feeds          |
|                      |               | ood/import |                |
+----------------------+---------------+------------+----------------+
| Corn MON 88017       | Monsanto      | January    | Expected       |
|                      |               | 2005       | December 2005  |
| High starch content  |               |            |                |
| -- Roundup Ready®    |               |            |                |
| and resistant to     |               |            |                |
| corn root worm       |               |            |                |
| (Diabrotica sp.)     |               |            |                |
+----------------------+---------------+------------+----------------+
| Roundup Ready® sugar | Monsanto/     | May 2005   | Expected       |
| beet H7-1            | German        |            | submission     |
|                      | company KWS   |            | Dec. 2005      |
+----------------------+---------------+------------+----------------+

Source: Ministry of Education and Science of the Russian Federation

## Production and Development

At present Russia officially does not produce any biotechnology crop
commercially. Only two biotechnology potato varieties, Bt potato Russet
Burbank NL (Monsanto) and Bt potato Superior NL (Monsanto), have
undergone all field tests, including tests on biosafety, and received
the biosafety registration in 2002 for 5 years. However, the Federal Law
of 2002 on Protection of Environment made biosafety registration
practically impossible, as this law stipulated insurmountable
requirements for environmental protection (Article 50 "Protection of
Environment from Negative Biological Impact" of the Federal Law). These
requirements are still in force as no amendments to this Federal Law
have been made to date.

In addition, due to the restructuring of the Russian Ministry of
Agriculture and suspension of registration of new varieties in the
Federal Register of varieties and hybrids allowed for planting on the
territory of the Russian Federation, these two biotech potato varieties
have not been included in the Register and cannot be used commercially.
The biosafety registration of these varieties expires in 2007. For more
information on the existent procedure of registration of all new
planting seeds in Russia see GAIN Report RS2004 sent January 31, 2002.

Looking forward to better times, two biotechnology crops are undergoing
field trials now: field trials of Monsanto's Roundup Ready® soybean
40-3-2 (glyphosate tolerant) and Monsanto's Roundup Ready® corn NK 603
(glyphosate tolerant) are being conducted on the isolated certified
fields at the All-Russian Scientific Research Institute of
Phyto-pathology (Moscow oblast) and at the All-Russian Scientific
Research Institute of Biological Plant Protection (Krasnodar kray).
However, none of the crops is expected to be approved for commercial use
in the near future, and certainly will not be in the market in the
coming year.

As long as the present biosafety requirements stipulated in the Federal
Law on Protection of Environment exist, registration of lines of
genetically modified crops for production will be practically
impossible. Obtaining a Biosafety Certificate would take at least two
additional years and would cost, according to experts' estimates, about
\$450,000. No firms producing bioengineered crops considers that expense
justifiable at this time. The requirement for biosafety certification
actually results in a de facto prohibition of importing not only seeds
of bioengineered crops, but also hampers importation of GMO grain and
oilseeds as well (corn and soybeans), because the kernels and seeds
"remain reproductively capable."

The requirement that a Biosafety Certificate be obtained has been the
main reason that, so far, bioengineered crops in Russia have been
registered only for imports for processing into food and for imports in
the form of feed meal. In the course of the administrative reform of the
Russian Federation government begun in Spring 2004, the Ministry of
Industry, Science and Technology was dismissed, the Biosafety Commission
of this Ministry disappeared, and all biosafety registration was
stopped. Up to now the Biosafety Commission has not been reestablished,
and possibly will not be, as Russia is developing a new structure of
safety standards: technical regulations that will determine the basic
safety requirements (for more information on the status of development
of technical regulations see GAIN Report #RS4062 "Russia to Start WTO
Inspired Legislative Revamp", sent 11/17/2004)

## Trade

Russia imports both food and feed containing products of biotechnology,
but specific trade data on imports of products containing such products
are not collected. Most imported products containing bio-engineered
varieties are produced from either corn or soybeans or have corn or
soybean components. Products made of soybean and corn are imported from
various countries, including Brazil, Argentina, the Netherlands and
United States. Most products imported from the Netherlands and some
other E.U. countries are processed in these countries from U.S.-origin
soybeans and corn. Phytosanitary restrictions imposed by the Russian
Federal Service for Veterinary and Phytosanitary Surveillance (VPSS) on
imports of plant products from E.U. member states in 2004-2005 (see GAIN
Report RS5052, sent 07/11/2005) also affected imports of products made
from soybeans, whether or not bioengineered.

All imported products may contain only registered biotech crops. The
product itself also shall be registered and certified based on the
registered crop. Registration of products and certification are required
both for foods and for feeds, but procedures for registration of GMO
food and GMO feeds are different.

## Food Aid

Russia is not a food aid beneficiary except for World Food Program
operations in Chechnya, which involve delivery of wheat and wheat flour,
and is not likely to be a food aid recipient in the near future.
However, practices of state or parastatal procurement of agricultural
products abroad for domestic food or feed supply still exist, and in
these cases imports of products are said to be made based on special
temporary permits. It is possible that these permits could circumvent
the framework requirements for imports of products containing biotech
crops.

# Biotechnology Policy

By 2002 Russia had adopted several laws that directly and indirectly
influence agricultural biotechnology, including the framework Law "On
Sanitary and Epidemiological Well-Being of the Population" of 1999 as
amended in 2001, 2003 and 2004; the Federal Law "On the State Regulation
in the Sphere of Genetic Engineering Activities " and the Federal Law
"On Protection of the Environment". These laws did not specify the
criteria, methods and directions of development of agricultural and food
biotechnology.

The regulatory basis for testing, examining and registration of GMO
events, food products and feeds was developed based on these laws by
different ministries and was put in force by a number of resolutions of
the Russian Government and by ministerial decrees issued by 2003.
However, in 2003 - 2004 the following drastic legislative changes
actually stopped for more than a year any further development of
agricultural biotechnology in Russia. First, the government
administrative reform of 2004 liquidated all previously existing
registration bodies, and along with reorganization of all ministries and
agencies their previous orders and regulations lost force.

Second, the Federal "Law on Technical Regulation" of December 2002,
which went into force in July 2003, revised principles of
standardization, and mandated that in 10 years Russian safety
requirements would be adjusted to international patterns. Instead of
numerous standards a few basic technical regulations should govern and
guarantee the safety of people, animals, and the environment in Russia.
The process of drafting basic technical regulations started in 2004 and
will continue through 2006.

## Status of Technical Regulations Concerning Biotechnology.

In November 2004 the government of the Russian Federation approved a
program of development of technical regulations (see GAIN Report RS4062,
sent 11/17/2004). Of the total seventy-four technical regulations that
will create the framework for safety of people, animals and environment
in Russia, two concern biotech crops. The first is called "Requirements
for the Biological Safety and Harmlessness of Genetically Modified
Plants". The timeframe for completion of draft regulation is November
2005, and the federal bodies participating in the development of the
draft are the Ministry of Agriculture, Ministry of Health and Social
Development, and Ministry of Industry and Energy.

The contractor for writing this regulation is a non-governmental
organization, the Russian Grain Union, and specialists engaged by the
Grain Union. The draft has not yet been published on the technical
regulation website, but publication is expected in the near future. The
second regulation is called "Requirements for the safety of food
products that have been produced from raw materials that are from
genetically modified plants or animals". The timeframe for completion of
draft regulation is November 2005, and the federal bodies in its
drafting are the Ministry of Health and Social Development, Ministry of
Agriculture of the Russian Federation, and Ministry of Industry and
Energy. The contractor for drafting this regulation is the Nutrition
Institute of the Russian Academy of Medical Sciences, and the draft is
already on the website of this institute for discussion.

## Present Regulatory Framework for Agricultural Biotechnology

After a hiatus in regulatory activity that started simultaneously with
administrative reform in Spring 2004 and as a result of the
disappearance of several Ministries, the total restructuring of all
other administrative bodies, and the disbanding of previous commissions,
the framework Interagency Commission for Genetic Engineering was
reestablished. The new Russian Ministry of Education and Science was
appointed to be in charge of coordination of research and development in
the field of bioengineering and thus authorized to create this
commission. Order #154 of the Ministry of Education and Science of May
27, 2005 approves the bylaws and membership (attached). The new
Commission has yet to meet to discuss any issues.

The Interagency Commission for Genetic Engineering is the main
policymaking and regulatory body for genetic engineering in Russia. The
Minister of Education and Science serves as chair. The Chairman has four
deputy chairs, of which two represent human and animal health and safety
surveillance authorities: the Federal Service for Veterinary and
Phytosanitary Surveillance (Rosselkhoznadzor) at the Ministry of
Agriculture, and Federal Service for Surveillance in the Sphere of
Protection of Consumer Rights and Well-being of People (Rospotrebnadzor)
at the Ministry of Health and Social Development. Two other deputies
represent research and development: the Deputy Head of the Federal
Agency for Science and Innovation at the Ministry of Education and
Science, and Director of the Bioengineering Center of the Academy of
Sciences of the Russian Federation. Members of the Commission represent
the majority of federal agencies and research institutes, and several of
the NGOs, involved in biotechnology and biotech-policy in Russia.

The Commission will participate in the development of government policy
for genetic engineering and biotechnology, will coordinate government
regulatory activity in the field of genetic engineering and
biotechnology, and will "coordinate issues of implementation and further
development of the licensing-and-information system for genetic
engineering and biotechnology including the issues related to the
improvement of Russian law for biotechnology and development of
scientific bases for the assessment and management of potential risks
related to biotechnology" (point 3.3 of the Guidelines). The Commission
will also participate in international collaboration in genetic
engineering, and will improve information available to the population on
the range of use of biotech products.

Most commission functions were inherited from the previous InterAgency
Commission on Genetic Engineering at the now defunct Ministry of
Industry, Science and Technology. The commission does not approve or
register new biotech events, but develops strategy and policy for
registration and in this sense remains the main decisionmaking and
permitting body on biotechnology in the Russian Federation.

If the authorities of the Interagency Commission remain the same as its
predecessor's, then all initiatives and undertakings in the field of
bioengineering in the Russian Federation, starting from imports of
samples for field trials, and extending to laboratory testing and
registration of events and products, will be authorized by the
commission in writing with the signature of its several members, with
the authorization prepared based on the minutes of the meetings of the
Commission. These authorities are not specified in the commission's
bylaws, but are implied.

## Responsible Government Ministries and Their Roles

[Registration for Food Use]{.underline}

All imported food products may contain only registered biotech events.
On July 1, 1999 the Russian Ministry of Health implemented a regulation
outlining the procedures required to register food products derived from
genetically modified sources. It applies to all foodstuffs sold through
retail channels, whether imported or produced domestically. In the
previous Government the Ministry of Health was responsible for
registration of events and biotechnology products for food consumption.
Food safety (food risk assessment) tests of these events and products
(separately) were conducted in the Nutrition Institute of the Academy of
Medical Sciences, with results going through the office of the Chief
Sanitary Physician of the Russian Federation for his approval before the
event or product was finally registered and approved by the Ministry of
Health.

The new system remains almost identical -- the new events and products
undergo food risk assessment tests and are examined in the Institute of
Nutrition, but approval and registration is now given directly by the
new service, Rospotrebnadzor, headed by the Chief Sanitary Physician of
the Russian Federation. The general registration procedures require
interested parties to submit an application accompanied by required,
supporting scientific documentation and samples. Review of the data and
samples will determine if further testing is required or if a
registration certificate can be issued based on the submitted
information. All data and technical information must be submitted in the
Russian language. Registration is initially valid for three years, but
renewals may be issued for five years.

Under the supervision of the Chief Sanitary Physician of the Russian
Federation, a system of monitoring of food products in the trade system
has been developed in order to detect biotechnology events. In
June-September 2002, the first attempt to monitor content of products of
biotechnology in food products were made in Moscow. Since that time,
more examinations have been conducted to make sure only properly
registered products are on grocery store shelves.

The list of bioengineered food products registered before 2002 is
available on the website of Rospotrebnadzor
([www.gsen.ru](http://www.gsen.ru/)). Recent updates have not been
posted.

[Registration for Feed Use]{.underline}

Registration for feed use has been discontinued along with liquidation
of the Expert Council for this registration at the Ministry of
Agriculture in the course of administrative reform. There are rumors the
council or an equivalent body will be reestablished soon at
Rosselkhoznadzor. The procedure for registration is likely to be the
same as before: the applicant will submit the same package of materials
as for the food registration, then after everything is examined the
event and product will be approved for feed use, and a registration
certificate issued. The certificates were signed previously by the First
Deputy Minister of Agriculture who oversaw veterinary issues, while in
the new structure, certificates most likely will be signed by the the
same individual, but in a new positions as head of Rosselkhoznadzor.

Registering lines of genetically modified whole grains and oilseeds
(corn and soybeans) for feed has been a much more difficult process than
registering meal, because a Biosafety Certificate from the Ministry of
Industry, Science and Technology was required as both corn and soybeans
"remain reproductive". It is not quite clear what the new procedure for
registration of GMO feeds and GMO grain for feed will be.

[Role and Membership of Biosafety Committee (if any)]{.underline}

The Biosafety Commission previously housed at the Ministry of Industry,
Science and Technology has been disbanded. Information on the possible
reestablishment of this commission or transfer of its functions to any
other agency is not available yet.

## Policy on Co-existence Between Biotechnology and Non-biotechnology Crops

There are no commercialized biotechnology crops. Tests are done on the
isolated and strictly controlled fields in the research institutes. On
sample plots in these institutes and laboratories researchers are
studying co-existence, but this is all at the laboratory level. One of
the arguments of opponents of biotech crops is that in Russia it is not
possible (or will be too expensive) to provide for necessary isolation
of GMO and non-GMO crops.

## Food Labeling

At the end of 2004 the Russian Federation Committee on Standards and
Metrology published standards to be used for food labeling in Russia
(National Standard of the Russian Federation GOST R 51074-2003 "Food
Products. Information for Consumers. General requirements," 2004). These
labeling standards apply to both domestically produced and imported food
products, and are presumed to have gone into effect officially on July
1, 2005. Many food processing companies have announced that they started
using these standards in January 2005.

The requirement for labeling products of biotechnology is one of most
controversial in the new standard. The standard stipulates,

> "Information on genetically modified food products, food products
> manufactured of genetically modified products, or food products
> containing components from genetically modified sources is mandatory.
> For food products containing components from genetically modified
> sources, the information is indicated if content of such components is
> higher than the rate set by a regulatory legal act (technical
> regulations). Consumer information on food products manufactured of
> genetically modified sources or containing genetically modified
> sources shall be stated on the label in the form of the following
> inscriptions: 'genetically modified ... (product name) ...,' or '...
> (product name) manufactured of genetically modified sources', or '...
> (product name) contains ingredients manufactured of genetically
> modified sources'. Information on use of genetically modified sources
> shall not be stated for products that do not contain protein (DNA)
> obtained from genetically modified sources."

(For information on voluntary food labeling requirements see GAIN Report
#RS4065 "New Voluntary Russian Food Labeling Requirements", sent
12/07/2004.)

On December 20, 2004, Russian President signed "Amendments to the Law of
the Russian Federation "On Protection of Consumer Rights". The new
edition of the Law adds "information on the presence in food products of
components from genetically modified sources" to the mandatory
information about the main consumer characteristics of food products. In
accordance with the new edition of the Federal Law "On Protection of
Consumer Rights", the information about any commodity (work, service)
shall start with the "Name of technical regulation or name of other
document certifying the conformity of commodity in accordance with the
law of the Russian Federation on technical regulation" (Article 10
"Information about commodities (works, services)\", item 2)

Unfortunately, however, the regulatory act (technical regulation)
setting the threshold for declaring presence of genetically modified
sources in food products has not yet developed, and, although at least
drafted, is not expected to be adopted before 2006. In the meantime, the
Chief Sanitary Physician of the Russian Federation decreased the
threshold from non-labeled presence of biotechnology-based raw material
in food products from 5 percent to 0.9 percent by his Order of April 6,
2004. The Order was not registered by the Russian Ministry of Justice,
and does not have force outside the authority of the agency of the Chief
Sanitary Physician, which is now the "Federal Service for Surveillance
in the Sphere of Protection of Consumers' Rights and Well-being of
People" (Rospotrebnadzor) at the Ministry of Health and Social
Development. Not formally being a legal requirement, then, but
nonetheless constituting an instruction of the primary public health
authority of the Russian government, the 0.9 percent threshold is a
threat to Russian food processors since the inspectors of
Rospotrebnadzor follow it as an internal instruction.

The situation has been exacerbated by the Greenpeace Russia that has
declared products of biotechnology to be the worst of all universal
threats to the health and well-being of the Russian people now and into
the future. In order to avoid hardships, most of the best, largest
Russian food processors have completely stopped buying raw materials and
ingredients where adventitious presence of GMO may be found and the
presence of GMO traces in the final products may exceed the 0.9 percent
threshold.

In addition, testing procedures have not yet been regularized, and two
testing methods are acknowledged as valid, which contributes to
unwelcome disputes. Trade in soybean products was affected most of all
by these decisions. Corn and soybean traders believe that if the 0.9
percent GMO labeling requirement is included in the technical
regulation, all food products processed from imported corn and soybeans
will have to be labeled. Given the present anti-GMO publicity campaign
of Greenpeace and other "environmental" NGOs, this labeling will affect
competitiveness of products of and thus penalize the most transparent
(i.e., law-abiding) food producers.

The 0.9 labeling threshold for GMO content remains in the draft of the
technical regulation "Requirements for the safety of food products that
have been produced from raw materials that are from genetically modified
plants or animals". In part this is motivated by a desire to harmonize
with European Union regulations in the belief that Russian can become an
exporter of "organic" foods to the European Union.

## Labeling for Feeds

Consumer labeling of feed is not required.

## Status of Ratification of Biosafety Protocol

Russia has not signed or ratified the Biosafety Protocol. The Russian
Customs Service is not aware of and does not require any document on the
conformity of the shipped samples with the Biosafety Protocol.

## Marketing Issues

The Russian consumer is presently aware of agricultural biotechnology,
and largely in a negative light due to a combination of widespread
yellow journalism and fear campaigns orchestrated by scaremongering
anti-biotechnology NGOs. As a result the imposition of labeling
requirements, particularly of products, which may have an adventitious
presence, is causing some retailers and many processors to shy away from
products and ingredients that may contain products of biotechnology.

Moscow, the biggest consumer market in Russia, has been affected by
these fears to the greatest extent, as "organic food" finds more and
more supporters among the richest strata of Moscow citizens, who
determine the Moscow food market preferences. Several sausage processors
heavily dependent on extenders have begun to advertise their products as
"GMO-free" in order to attract customers. The Moscow City Government
also pursues an anti-biotechnology policy, and in March 2005 established
the Coordination Council on Safety of Food Products Derived from GMO,
significantly influenced by the NGO "National Association for Genetic
Safety," and gave this Council the authority to monitor presence of GMO
in food products. The National Association for Genetic Safety, although
it does not have any legal authority, goes as far as calling for
criminal liability for those producers who voluntary or involuntary mask
the presence of GMO in their food products.

Provincial politicians have also warned their citizens to avoid U.S.
products, including U.S. poultry mean, which they claim are "carriers"
of genetically modified material since the birds are fed meal from
bioengineered soybeans and corn. Belgorod oblast Governor Yevgeniy
Savchenko has declared his province a GMO-free zone and publicly vowed
to prohibit application of agricultural biotechnology there, while
calling for a total ban on imports of products of biotechnology.

At the regulatory level, the inability for all practical purposes to
register seeds for planting of biotechnology varieties has closed the
market to U.S. seeds of bioengineered strains. The biosafety
certification requirement has disadvantaged U.S. whole corn and soybeans
due to the inability to guarantee that spilled beans or corn might not
result in adventitious growth of biotech soybeans or corn in Russia.

Officials of the Russian government view regulation of imported products
of biotechnology as a means of controlling imports, and thus are
prepared to use phytosanitary regulations as a trade barrier. They are
equally prepared to waive regulations to permit imports when it suits
them.

## Capacity Building and Outreach

Compared to the resources employed by anti-biotechnology NGOs, the
resources of pro-biotechnology forces in Russia are meager when it comes
to outreach. A Bioengineering Center of the Academy of Sciences exists,
and features a website with information on biotechnology in Russia, but
otherwise little action is visible.

Agricultural science in Russia is in a state of decline with federal
funding for basic research, even in the hard biological sciences,
practically gone, according to the president of the Academy of
Agricultural Sciences. Russian biotechnology researchers publish less
than one-tenth the number of publications their American counterparts
do. The research institutes cannot compete with private firms and
laboratories for young scientific workers and researchers, with the
result that the population of scientifically well grounded experts in
biotechnology is not only shockingly limited, it is aging and thus
declining over time. The result is a level of scientific illiteracy
surrounding biotechnology that increases the fears and doubts of what is
viewed as an "American" innovation, and which will get worse before it
can possible hope to get better.

# Reference Materials

## Decree on Creation of the Interagency Commission for Genetic Engineering, Guidelines and List of Members of Commission

Unofficial translation

D E C R E E

27.05.2005 Moscow N 154

On the Interagency Commission for Genetic Engineering

In compliance with the Guidelines on the Ministry of Education and
Science of the Russian Federation of June 15, 2004 No. 280, I hereby
**decree:**

1\. Establish the Interagency Commission for Genetic Engineering
(hereinafter referred to as the \"Commission\").

2\. Approve:

2.1 Regulations on the Commission (Appendix 1)

2.2 Member of the Commission (Appendix 2)

3\. The Federal Agency for Science and Innovations (S.N. Mazurenko) to
be responsible for the organizational and administrative issues related
to the activity of the Commission.

4\. Supervision over the execution of this Decree shall be provided by
the Ministry of Education and Science of the Russian Federation (A.
Fursenko)

Minister A. Fursenko

**Appendix 1**

Approved\
[[by the Order of the Ministry of Education and Science of the Russian
Federation\
of May 27, 2005 N
154]{.underline}](http://edu.ru/db/mo/Data/d_05/m154.html)

**GUIDELINES\
on Interagency Commission for Genetic Engineering**

1\. The Interagency Commission for Genetic Engineering (hereinafter
referred to as the \"Commission\") is a coordinating agency established
to coordinate the activity of the federal executive authorities
\[letters of the Russian Ministry of Health (of February 24, 2005 N
806-ВС), Russian Ministry of Agriculture (of February 24, 2005 N
СМ-13/644), Russian Ministry of Industry (of March 10, 2005 N 03-12-
38/1754)\] in order to develop genetic engineering and biotechnology,
and provide necessary safety in these fields of industry.

2\. The Commission shall work in accordance with the Constitution of the
Russian Federation, federal constitutional law, federal laws, Decrees
and Resolutions of the President of the Russian Federation, Decrees and
Resolutions of the Russian government, legislative documents of the
Russian Ministry of Education and Science, and these Guidelines.

3\. Main objectives of the Commission:

3.1 Participate in the development of proposals for the establishment
and implementation of state policy for genetic engineering and
biotechnology

3.2 Cooperation with federal executive authorities, local authorities,
scientific, educational and other organizations to provide coordinated
activity for state regulation in the field of genetic engineering and
biotechnology.

3.3 Coordinate issues of implementation and further development of the
licensing-and-information system for genetic engineering and
biotechnology including the issues related to the improvement of Russian
law for biotechnology and development of scientific basis for the
assessment and management of potential risks related to biotechnology.

3.4 Participate in international collaboration in genetic engineering.

3.5 Improve information for the population on the range of use of
biotech products.

3.6 Submit to the Russian Government in due form an annual report on the
Commission's activity.

4\. In order to fulfill its obligations, the Commission shall consider
proposals and if necessary shall issue the following recommendations:

4.1 On working out measures aimed at the support and development of
priority directions for genetic engineering and biotechnology in the
Russian Federation.

4.2 On drafts of legislative acts related to the development and
improvement of infrastructure and control system for biotechnology
safety, including the development of scheme for the safe development,
use and transfer of genetically modified organisms, or their fractions,
or genetic engineering technologies.

4.3 On the expediency of issuing specific approvals (notices) valid in
the Russian Federation in order to secure safety related to genetic
engineering and biotechnology.

4.4 On the organization, conducting and participation in conferences and
seminars including international events, with subjects related to the
Commission activity.

4.5 On preparation and publication of scientific, methodological and
information materials related to the Commission activity.

5\. The Commission shall be authorized to:

5.1 Conduct hearings at the Commission\'s meetings on reports of the
Commission members on subjects covered by the Commission.

5.2 Request in proper order materials related to the Commission\'s
activity from the federal executive authorities, local authorities,
scientific, educational, and other organizations.

5.3 Take decisions within the scope of the Commission\'s competence
required for coordination of steps taken by federal executive
authorities, local authorities, scientific, educational and other
organizations in the field of genetic engineering and biotechnology and
safety of such.

5.4 Invite as appropriate representatives of interested federal
executive authorities, scientific, educational and other organizations,
leading scientists and experts to assist in effective fulfillment of a
specific task or suggestion, and execute necessary procedure.

5.5 Prepare as appropriate corresponding proposals for submission to the
Government of the Russian Federation.

6\. The Commission is to be headed by the Minister of Education and
Science of the Russian Federation.

The Commission shall include representatives of federal executive
authorities. Members of the Commission can represent a legislative body,
scientific, educational or other organizations, or public associations,
the activity of which is related to biotechnology or genetic
engineering. Such members of the Commission shall have the right to
vote.

The Guidelines and members of the Commission to be approved by the
Ministry of Education and Science of the Russian Federation.

7\. To be effective, the Commission can set up sections, among them a
scientific and information-and-analytical section, as well as temporary
or standing working groups.

The list of sections, temporary or standing working groups and members
of such to be discussed at the Commission meetings and approved by the
Chairman.

8\. The Commission shall be working on the basis of an annual plan
approved by the Chairman.

Meetings of the Commission shall be held when necessary but not less
than three times a year.

Members of the Commission shall participate in Commission sessions
without the right of proxy.

Sessions of the Commission to be considered to have a quorum if not
fewer than 50% of the Commission members are present. Decisions of the
Commission are to be taken by a simple majority vote and legalized by
minutes of the meeting signed by the Chairman or Deputy Chairman of the
Commission, chair of the meeting, and Executive Secretary of the
Commission.

If a member of the Commission is not in a position to attend the
meeting, he can submit his opinion in writing. In this case, such a
statement shall be read out at the meeting and attached to the minutes.

Representatives of the federal executive authorities, local executive
authorities, legislative body, scientific or other organizations,
scientists, experts or public activists who are not members of the
Commission may be invited to participate in the Commission meetings.

Decisions taken by the Commission within its competence are binding to
all authorities and organizations represented in the Commission as well
as to all companies and institutions under such authorities, who shall
be notified accordingly by extracts from the minutes.

9\. Organizational and logistical support for the Commission shall be
provided by the Federal Agency for Science and Innovation on the basis
of an instruction from the Ministry of Education and Science of the
Russian Federation.

**Appendix 2**

Approved\
[[by the Order of the Ministry of Education and Science of the Russian
Federation\
of May 27, 2005 N
154]{.underline}](http://edu.ru/db/mo/Data/d_05/m154.html)

**MEMBERS**

**of Interagency Commission for Genetic Engineering**

+---------------------------+------------------------------------------+
| Andrey A. Fursenko        | Minister of Education and Science of the |
|                           | Russian Federation                       |
| (Chairman)                |                                          |
+---------------------------+------------------------------------------+
| Inna P. Bilenkina         | Deputy, Head of the Federal Agency for   |
|                           | Science and Innovation                   |
| (Deputy Chairman)         |                                          |
+---------------------------+------------------------------------------+
| Sergey A. Dankvert        | Head, Federal Service for Veterinary and |
|                           | Phytosanitary Surveillance, Ministry of  |
| (Deputy Chairman)         | Agriculture                              |
+---------------------------+------------------------------------------+
| Gennadiy G. Onishchenko   | Head, Federal Service for Consumer       |
|                           | Rights and Human Welfare, Chief State    |
| (Deputy Chairman)         | Sanitary Physician of the Russian        |
|                           | Federation, full member of the Russian   |
|                           | Academy of Medical Sciences              |
+---------------------------+------------------------------------------+
| Konstantin G. Skryabin    | Director, Center \"Bioengineering\" RAS, |
|                           |                                          |
| (Deputy Chairman)         | full member of the Russian Academy of    |
|                           | Agricultural Sciences                    |
+---------------------------+------------------------------------------+
| Yevgeniy N. Oreshkin      | Head of Department, Federal Agency for   |
|                           | Science and Innovations                  |
| (Executive Secretary)     |                                          |
+---------------------------+------------------------------------------+
| Amirkhan M. Amirkhanov    | Deputy Director, Department for State    |
|                           | Policy in Environmental Protection,      |
|                           | Ministry of Natural Recourses of Russia  |
+---------------------------+------------------------------------------+
| Iosif G. Atabekov         | Head, Faculty of Virology, Biological    |
|                           | Department, Moscow State University,     |
|                           | full member of the Russian Academy of    |
|                           | Sciences and full member of the Russian  |
|                           | Academy of Agricultural Sciences         |
+---------------------------+------------------------------------------+
| Nikolay P. Bochkov        | Vice-president, Russian Academy of       |
|                           | Medical Sciences,                        |
|                           |                                          |
|                           | full member of the Russian Academy of    |
|                           | Medical Sciences                         |
+---------------------------+------------------------------------------+
| Elena V. Budaeva          | Deputy Head, Main Administration for     |
|                           | Trade Nomenclature and Trade             |
|                           | Restrictions, Federal Customs Service    |
+---------------------------+------------------------------------------+
| Mikhail S. Bunin          | Deputy Director, Department of           |
|                           | Scientific-and-Technical Policy and      |
|                           | Education, Ministry of Agriculture of    |
|                           | Russia                                   |
+---------------------------+------------------------------------------+
| Nikifor T. Vasiliyev      | Head of Administration, Deputy           |
|                           | Commander-in-Chief, Military Units for   |
|                           | Radiological, Chemical and Biological    |
|                           | Protection, Ministry of Defense of       |
|                           | Russia                                   |
+---------------------------+------------------------------------------+
| Nikolay N. Volodin        | Director, Department of Pharmaceuticals, |
|                           | Human Welfare, Science and Education,    |
|                           | Ministry of Health and Social            |
|                           | Development of Russia, full member of    |
|                           | the Russian Academy of Medical Sciences  |
+---------------------------+------------------------------------------+
| Anatoliy I. Grigoriyev    | Academic Secretary of the Russian        |
|                           | Academy of Sciences, Director, Institute |
|                           | of Medical and Biological Issues, full   |
|                           | member of the Russian Academy of         |
|                           | Sciences                                 |
+---------------------------+------------------------------------------+
| Arkadiy L. Zlochevskiy    | President, Non-commercial Association    |
|                           | \"Russian Grain Union\"                  |
+---------------------------+------------------------------------------+
| Vadim T. Ivanov           | Director, Shemyakin & Ovchnnikov         |
|                           | Institute of Bio-organical Chemistry,    |
|                           | full member of the Russian Academy of    |
|                           | Sciences                                 |
+---------------------------+------------------------------------------+
| Yuriy T. Kalinin          | President, Rosmedprom (Russian           |
|                           | Association of Producers and Suppliers   |
|                           | of Pharmaceuticals, Medical Products and |
|                           | Equipment)                               |
+---------------------------+------------------------------------------+
| Mikhail P. Kirpichnikov   | Vice Rector, Moscow State University,    |
|                           | full member of the Russian Academy of    |
|                           | Sciences                                 |
+---------------------------+------------------------------------------+
| Mikhail A. Komarov        | First Deputy Head, Legal Department,     |
|                           | Federal Customs Service                  |
+---------------------------+------------------------------------------+
| Olga F. Kostyleva         | Deputy Head, Administration for          |
|                           | Technical Regulation and Standards,      |
|                           | Federal Agency for Technical Regulation  |
|                           | and Metrology                            |
+---------------------------+------------------------------------------+
| Gennadiy V. Kulik         | Chairman, Agricultural Committee, State  |
|                           | Duma                                     |
+---------------------------+------------------------------------------+
| Pavel I. Melnichenko      | Chief State Sanitary Physician of the    |
|                           | Ministry of Defense. Deputy Head, Chief  |
|                           | Military Medical Administration,         |
|                           | Ministry of Defense of the Russian       |
|                           | Federation for Sanitary and              |
|                           | Epidemiological Security                 |
+---------------------------+------------------------------------------+
| Yevgeniy A. Nepoklonov    | Deputy Head, Federal Service for         |
|                           | Veterinary and Phytosanitary             |
|                           | Surveillance, Ministry of Agriculture    |
+---------------------------+------------------------------------------+
| Aleksander N. Panin       | Director, All-Russian State Center for   |
|                           | Quality and Standardization of           |
|                           | Veterinary Drugs and Feed,               |
|                           | Rosselkhonadzor, full member of the      |
|                           | Russian Academy of Agricultural Sciences |
+---------------------------+------------------------------------------+
| Andrey V. Pechkurov       | Deputy Head, Administration for          |
|                           | Environmental Supervision and            |
|                           | Inspection, Federal Agency for           |
|                           | Ecological, Technological and Atomic     |
|                           | Inspection                               |
+---------------------------+------------------------------------------+
| Iosif A. Rogov            | Rector, Moscow State University of       |
|                           | Applied Biotechnology and Chairman,      |
|                           | Russian Meat Union, full member of the   |
|                           | Russian Academy of Agricultural Sciences |
+---------------------------+------------------------------------------+
| Gennadiy A. Romanenko     | President, Russian Academy of            |
|                           | Agricultural Sciences,                   |
|                           |                                          |
|                           | full member of the Russian Academy of    |
|                           | Agricultural Sciences                    |
+---------------------------+------------------------------------------+
| Ivan K. Rozhdestvenskiy   | Head, Veterinary Administration, Federal |
|                           | Service for Veterinary and Phytosanitary |
|                           | Surveillance                             |
+---------------------------+------------------------------------------+
| Lev S. Sandkhchiyev       | General Director, Vektor Center for      |
|                           | Virology and Biotechnology, Ministry of  |
|                           | Health and Social Development of Russia, |
|                           | full member of the Russian Academy of    |
|                           | Medical Sciences                         |
+---------------------------+------------------------------------------+
| Igor A. Tikhonovich       | Director, All-Russia Research Institute  |
|                           | of Agricultural Microbiology, full       |
|                           | member of the Russian Academy of         |
|                           | Agricultural Sciences                    |
+---------------------------+------------------------------------------+
| Viktor A. Tutelyan        | Director, Research Institute of          |
|                           | Nutrition, Russian Academy of Medical    |
|                           | Sciences, full member of the Russian     |
|                           | Academy of Medical Sciences              |
+---------------------------+------------------------------------------+
| Ramil U. Khabriyev        | Head, Federal Service for Inspection in  |
|                           | Healthcare and Social Development,       |
|                           | corresponding member of the Russian      |
|                           | Academy of Medical Sciences              |
+---------------------------+------------------------------------------+
| Sergey V. Shestakov       | Head, Faculty of Genetics, Biological    |
|                           | Department, Moscow State University,     |
|                           | full member of the Russian Academy of    |
|                           | Sciences                                 |
+---------------------------+------------------------------------------+
| Lev K. Ernst              | Vice-president, Russian Academy of       |
|                           | Agricultural Sciences, full member of    |
|                           | the Russian Academy of Agricultural      |
|                           | Sciences                                 |
+---------------------------+------------------------------------------+