Required Report - public distribution

**Date:** 7/15/2005

**GAIN Report Number:** UP5012

UP5011

**Ukraine**

**Biotechnology**

**Ukraine Agricultural Biotechnology Report**

**2005**

**Approved by:**

![](media/image1.wmf)W. Garth Thorburn II, Agricultural Attaché

U.S. Embassy

**Prepared by:**

Dmitri Prikhodko, Agricultural Specialist

**Report Highlights:**

The current regulatory process for the approval of biotech crops in
Ukraine is not well defined and is based on registration procedures
designed for the conventional plant varieties. Efforts to establish a
more efficient biotechnology regulatory framework stalled in Parliament
in 2002. Since there have been no biotechnological varieties approved
and registered in Ukraine, the government considers Ukraine free of
biotech products. Some doubt exists to that claim.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Kiev \[UP1\]

\[UP\]

Table of Contents

[Section I. Executive Summary 2](#section-i.-executive-summary)

[Section II. Biotechnology Trade and Production.
3](#section-ii.-biotechnology-trade-and-production.)

[Production 3](#production)

[Trade Impact 3](#trade-impact)

[Section III. Biotechnology Policy
5](#section-iii.-biotechnology-policy)

[Genetically Modified Crops That Went Through Field Trials in Ukraine.
5](#genetically-modified-crops-that-went-through-field-trials-in-ukraine.)

[Labeling 6](#labeling)

[Biosafety Protocol 6](#biosafety-protocol)

[Section IV. Marketing Issues 6](#section-iv.-marketing-issues)

[Section V. Capacity Building and Outreach
7](#section-v.-capacity-building-and-outreach)

[Appendices 8](#appendices)

[Appendix A. Ukraine's Biotechnology Regulatory Process As It Currently
Applies to Biotech Crops
8](#appendix-a.-the-scheme-of-ukraines-biotechnology-regulatory-process-as-it-currently-applies-to-biotech-crops.)

[Appendix B. Steps Necessary To Register a Biotech Crop in Ukraine
9](#appendix-b.-steps-necessary-to-register-a-biotech-crop-in-ukraine)

[Appendix C. Major Responsibilities As Per the Draft Law of Ukraine "On
the State Biosafety System for Development, Testing and Usage of the
Genetically Modified Organisms".
10](#appendix-c.-agency-responsibilities-as-per-the-draft-law-of-ukraine-on-the-state-biosafety-system-for-development-testing-and-usage-of-genetically-modified-organisms.)

# Section I. Executive Summary

Imports of food and agricultural products in Ukraine totaled \$1.9
billion (CIF value) in 2004. United States captured 7% (\$129 million)
of the import market behind Russia, Brazil and Germany. Poultry meat,
fish, tobacco, planting seeds, soybean meal, pet food, proteins derived
from soybeans and tree nuts are the major US food and agricultural items
exported to Ukraine. According to FAS-Kiev estimates, the value of U.S.
soybean meal, soy proteins and isolates, corn products, planting seeds
and other products that faced or could have encountered trade
restrictions because of unclear biotechnology regulations ranged from
\$**1.1 million (2003) to \$6.0 million (2002)**. Issues of market
access for products of agricultural biotechnology are expected to become
more critical as Ukraine will increase its oilseed processing capacity
and will enforce GM labeling regulations.

Ukraine has a number of biotechnology policy issues that impact trade.
Lack of legislation that would establish a biosafety regulatory
framework hinders registration of biotech crops. Unclear GMO food
labeling regulations and the great degree of latitude exercised by
various regulatory officials at the border do not encourage fair
competition. Uncertainty over implementation of the Cartagena Protocol
will discourage imports of bulk agricultural commodities.

The Ukrainian government (GOU) authorized filed trials of biotech crops
along with an environmental and food safety assessment in 1998. Insect
resistant (Bt) potatoes and herbicide tolerant sugar beets, corn and
rapeseed underwent full-scale field trials in 1998-2000. None have
received final approval, however, due to the lack of decision-making
authority. There have been no new applications for registration of
biotech crops since then because of uncertainty over the length of the
approval process. Ukraine has no functioning biosafety regulatory
framework at this point. Draft legislation that would delegate
regulatory authority to relevant GOU agencies has been pending final
approval by the Ukrainian Parliament since November 2002.

In the future, Ukraine will most likely adopt biotechnology policies
that mirror those applied in the EU. However, there is a possibility
that the Ukrainian government will allow the agricultural industry,
consumers and the environment to benefit from biotech products
considering the remote possibility of EU membership.

# Section II. Biotechnology Trade and Production. 

## Production

Ukraine has not approved a single biotechnology crop for commercial
production despite having received five applications in 1997-1999.
Therefore, authorities believe that Ukraine's agriculture remains
GMO-free. A weak regulatory system, the lack of field surveillance
programs and laboratory capacities, however, leave doubt to Ukraine's
GMO free status.

Ukrainian researchers in cooperation with a Russian scientist reportedly
developed potatoes resistant to the X-virus in 1990. This was the first
transgenic plant in the Former Soviet Union (FSU). Since then, research
in this area has continued in the Institute of Cell Biology and Genetic
Engineering (ICBGE) of the National Academy of Sciences of Ukraine, and
Institutes of the Ukrainian Academy of Agricultural Sciences. According
to available information, Ukrainian researchers developed transgenic
sugar beets, potatoes, tobacco, rapeseeds, cabbage, alfalfa, soybeans,
peas, flax, barley, buckwheat, and African millet. Most of these plants
were developed for scientific purposes using non-patented technologies
and utilized germplasm of the local varieties to gain insect resistance
or herbicide tolerance.

Reportedly, scientists from the ICBGE developed transgenic soybeans,
flax and African millet with *dinitranilin* resistant features
(*Treflan* and other herbicides produced by DowAgro Sciences Co.)
However, the technology has not yet been patented. All plants remain in
the laboratory environment and have gone through the seed propagation
stage. Ukrainian scientists also developed technology for plant
recombinant proteins used in pharmacology \-- -interferon and
somatropine (human growth hormone). However, this technology has not yet
been commercialized.

## Trade Impact

The lack of an established and operational biotechnological regulatory
framework in Ukraine impacts trade as some regulatory officials use
biotechnology as a justification for trade restrictions. The Ukrainian
veterinary service tried to use the issue of "genetically modified
feeds" used in poultry feed in the United States as a reason to block
trade in poultry meat in 2002. This issue was discussed and eliminated
during negotiations between the USDA and the State Department of
Veterinary Medicine of the Ministry of Agricultural Policy of Ukraine in
March 2003.

On occasion, local food safety officials have been known to demand from
traders proof that imported commodities, mainly soybeans and soybean
meal, are GM free. This occurs despite the fact that there are no
published regulations banning the import of GM feed products.

In September 2000, a joint order from the Ministry of Agricultural
Policy of Ukraine and the Ukrainian Academy of Agricultural Sciences
(UAAS) prohibited the importation of honey and bee products that were
byproducts of "bees fed with GMO-containing feeds". Although scientific
justifications that support this measure do not exist, the order remains
in effect. This order points to one of the major weaknesses of the
Ukrainian regulatory system -- involvement of non-regulatory agencies in
the decision making process.

FAS-Kiev summarized data on Ukraine's imports of the following major
products that might contain biotech corn or soybean events: Corn Flour
(HS 110220); Corn Meal or Groat (HS 110313); Worked Corn (HS 110423);
Soybeans (HS 120100); Soy Sauce (HS 210310); Protein Concentrates (HS
210610); Corn Gluten (HS 230310); Soybean Meal (HS 230400); Protein
Isolates (HS 350400). Prepared food products and feeds were not targeted
in this research.

Ukraine imported products valued at \$35 million in 2004 that could
contain GMOs. Surprisingly, the United Stats appears to be only the
third largest supplier of these products after Brazil and the
Netherlands, Ukraine's major suppliers of soybean meal (see the graph
below).

![](media/image2.wmf){width="4.723611111111111in"
height="3.0756944444444443in"}

The following table illustrates U.S. exports of food and agricultural
commodities that are affected, or might be affected, by Ukraine's
biotech regulations in the future.

**Imports of U.S. Products that Could be Affected by Ukraine's Biotech
Regulations (CIF, \$ 1,000)**

<table style="width:100%;">
<colgroup>
<col style="width: 8%" />
<col style="width: 27%" />
<col style="width: 8%" />
<col style="width: 6%" />
<col style="width: 8%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>HS Code</strong></td>
<td rowspan="2"><strong>Description</strong></td>
<td colspan="2"><strong>2002</strong></td>
<td colspan="3"><strong>2003</strong></td>
<td colspan="3"><strong>2004</strong></td>
<td colspan="2"><strong>2002-2004 average</strong></td>
</tr>
<tr class="even">
<td><strong>Value $1,000</strong></td>
<td><strong>Share %</strong></td>
<td><strong>Value $1,000</strong></td>
<td colspan="2"><strong>Share %</strong></td>
<td colspan="2"><strong>Value $1,000</strong></td>
<td><strong>Share %</strong></td>
<td><strong>Value $1,000</strong></td>
<td><strong>Share %</strong></td>
</tr>
<tr class="odd">
<td>230400</td>
<td>SOYBEAN MEAL</td>
<td>2,741</td>
<td>46%</td>
<td>237</td>
<td colspan="2">21%</td>
<td colspan="2">1,184</td>
<td>51%</td>
<td>1,387</td>
<td>44%</td>
</tr>
<tr class="even">
<td>350400</td>
<td>PEPTONE, PROTEIN ISOLATES</td>
<td>154</td>
<td>3%</td>
<td>426</td>
<td colspan="2">37%</td>
<td colspan="2">1,040</td>
<td>45%</td>
<td>540</td>
<td>17%</td>
</tr>
<tr class="odd">
<td>210610</td>
<td>PROTEIN CONCENTRATE</td>
<td>11</td>
<td>0%</td>
<td>12</td>
<td colspan="2">1%</td>
<td colspan="2">53</td>
<td>2%</td>
<td>25</td>
<td>1%</td>
</tr>
<tr class="even">
<td>120100</td>
<td>SOYBEANS</td>
<td>2,599</td>
<td>43%</td>
<td>64</td>
<td colspan="2">6%</td>
<td colspan="2">44</td>
<td>2%</td>
<td>902</td>
<td>28%</td>
</tr>
<tr class="odd">
<td>210310</td>
<td>SOY SAUCE</td>
<td>18</td>
<td>0%</td>
<td>10</td>
<td colspan="2">1%</td>
<td colspan="2">14</td>
<td>1%</td>
<td>14</td>
<td>0%</td>
</tr>
<tr class="even">
<td>230310</td>
<td>CORN GLUTEN</td>
<td>278</td>
<td>5%</td>
<td>404</td>
<td colspan="2">35%</td>
<td colspan="2">0</td>
<td>0%</td>
<td>227</td>
<td>7%</td>
</tr>
<tr class="odd">
<td>110423</td>
<td>WORKED CORN</td>
<td>221</td>
<td>4%</td>
<td>0</td>
<td colspan="2">0%</td>
<td colspan="2">0</td>
<td>0%</td>
<td>74</td>
<td>2%</td>
</tr>
<tr class="even">
<td colspan="2"><h6 id="total">Total</h6></td>
<td><strong>6,023</strong></td>
<td><strong>100%</strong></td>
<td><strong>1,155</strong></td>
<td colspan="2"><strong>100%</strong></td>
<td colspan="2"><strong>2,335</strong></td>
<td><strong>100%</strong></td>
<td><strong>3,171</strong></td>
<td><strong>100%</strong></td>
</tr>
<tr class="odd">
<td colspan="6"><p
id="data-source-state-statistics-committee-of-ukraine"
class="heading">Data source: State Statistics Committee of Ukraine
</p></td>
<td colspan="2"></td>
<td colspan="4"></td>
</tr>
</tbody>
</table>

Future impact of trade in biotechnology, however, should not be guided
only on the information provided in the table above. Two new crushing
plants capable of crushing soybeans are scheduled to begin operations in
the Port of Illichivsk (near Odessa) in MY 2005/2006. Although,
currently there are no plans for these facilities to import soybeans for
crushing, it is highly probable that soybeans will be imported in the
future assuming favorable crushing margins and the existence of clear
regulations governing imports of GM soybeans. Imports of 50,000 MT of
soybeans may increase the value of trade that is subject to biotech
regulations by **\$13 million**.

Issues related to the presence of biotechnology products in food
assistance programs are not expected to have any significant importance
in the future. The Ukrainian government and non-government organizations
received agricultural products under various U.S. food assistance
programs in 1995-2000. Since then, the country has not faced problems
with commercial food imports, hard currency shortages or foreign
exchange. Ukraine is by far a net food exporter and will not likely
require any food assistance in the future.

# Section III. Biotechnology Policy

Ukraine is in the process of developing its national biosafety
regulatory system. Currently, there is no legislation in place to govern
environmental, food or feed safety assessments of GMOs. The country,
however, developed legislation to require GMO food labeling, signed the
Cartagena protocol and has provisional procedures for biotech crop
registration.

In response to the first application to register a biotech crop, the
Cabinet of Ministers of Ukraine approved provisional procedures for
testing GM crops in 1998 and authorized the State Service on Protection
of Plant Variety Rights under the Ministry of Agricultural Policy of
Ukraine to coordinate this process. The Interagency Biosafety Commission
under the Ministry of Science and Education of Ukraine reviewed the
initial application from the companies and conducted an environmental
risk assessment. Five biotech crops (see the table below) underwent
field trials in 1997-2000. However, due to the absence of a legislative
framework and the lack of decision-making authority, none has received
final approval

## Genetically Modified Crops That Went Through Field Trials in Ukraine. 

+--------------------------+--------+--------+-------+--------+------+
| **Trait**                | #      | **     | **A   | **Year | **   |
|                          | ###### | Number | pplic | of     | Stat |
|                          | # Crop | of     | ant** | a      | us** |
|                          |        | varie  |       | pplica |      |
|                          |        | ties** |       | tion** |      |
+--------------------------+--------+--------+-------+--------+------+
| BT (insect resistance)   | Po     | 3      | Mon   | 1997   | Pen  |
|                          | tatoes |        | santo |        | ding |
+--------------------------+--------+--------+-------+--------+------+
| Glyphosinate tolerance   | Sugar  | 1      | Sy    | 1998   | Pen  |
| (Liberty Link)           | beets  |        | ngent |        | ding |
|                          |        |        | a/Mon |        |      |
|                          |        |        | santo |        |      |
+--------------------------+--------+--------+-------+--------+------+
| BT (insect resistance)   | Corn   | 1      | Syn   | 1998   | Pen  |
|                          |        |        | genta |        | ding |
+--------------------------+--------+--------+-------+--------+------+
| Glyphosinate tolerance   | Ra     | 1      | Bayer | 1998   | N/A  |
| (Liberty Link)           | peseed |        |       |        |      |
+--------------------------+--------+--------+-------+--------+------+
| Glyphosate tolerance     | Corn   | 1      | Mon   | 1998   | Pen  |
| (Roundup)                |        |        | santo |        | ding |
+--------------------------+--------+--------+-------+--------+------+

The current regulatory process for approval of biotech crops in Ukraine
is very cumbersome. It is based on mandatory registration procedures
designed for conventional plant varieties. However, a biotech plant
variety is required to go through a more rigid and lengthy registration
process than a variety using conventional plant breeding. According to
provisional procedures that are still in place, legal steps necessary
for registering biotech crops are outlined in Appendices A and B.

The Draft Law of Ukraine "On the State Biosafety System for Developing,
Testing and Usage of Genetically Modified Organisms", which was prepared
to address the legislative vacuum, passed the first reading in the
Ukrainian Parliament in November 2002. The Law has been pending final
approval by Parliament since then. According to the proposed
legislation, regulatory responsibilities will be divided amongst the
Ministries of Education and Science (MES), Environment and Natural
Resources (MENR), Health Care (MHC), Agricultural Policy (MAP) and a
special regulatory agency - Interagency Commission on Biosafety (ICB).
Once the law is adopted, these regulatory agencies will develop
implementing regulations. The authority of each regulatory agency as
specified in the draft law is outlined in Appendix C.

Ukraine has not approved any biotechnology crops for food, processing or
feed as there are no applicable regulations governing food or feed
safety assessment of GMOs.

It is not yet clear how the Ukrainian regulatory system will treat
"stacked" biotechnology events (plants that combine two already approved
traits, such as herbicide tolerance and insect resistance). The biotech
event will require only one registration with the Interagency Biosafety
Commission in accordance with the yet-to-be-approved draft biosafety
legislation. However, agricultural authorities in charge of plant
variety rights protection will most likely require a separate
registration for each new variety that contains a new trait.

The domestic organic farming industry is just beginning to establish;
therefore, there are no official or industry organic standards at this
point. Some Ukrainian farms were certified as organic by EU-based
institutions. Peaceful coexistence between organic and biotech crops in
Ukraine is unlikely. Organic soybean producers in Ukraine have already
called for a ban on GM crop plantings.

## Labeling

While there are no labeling requirements applicable to biotech feeds,
Ukraine's current GMO labeling rules represent one of the major
uncertainties for food importers. Food products that contain GMOs were
not regulated prior to October 24, 2002, the date when the Parliament of
Ukraine incorporated changes into the Law of Ukraine On Food Safety. The
legislation included food products that contain "genetically modified
components" to the category of new food products along with newly
developed foods, products that have not been imported before, products
that contain new components/ingredients and products that were produced
using new technology. A separate line on the presence of GMOs in food
products was included to the list of mandatory information to be
provided on the label. It appears that any quantity of GMOs must be
labeled according to the Law.

This legislation was adopted to reflect the consumers' "right to know"
because the GOU does not conduct food safety risk assessments for GMOs
at this point. The current labeling legislation is unclear on label
language, placement or threshold. The implementing regulations entitled
"On Approving Rules of Retail Trade in Food Products" adapted by the
Ministry of Economy of Ukraine on July 23, 2003 did not clarify these
issues. The regulations simply prohibited the sale of domestically
produced and imported consumer packaged food products that do not have
an "easy to comprehend" label. **So far, the domestic food industry and
food importers have ignored GMO labeling requirements due to the lack of
clarity and enforcement.**

## Biosafety Protocol

Ukraine ratified the Protocol on Biosafety to the Convention on
Biological Diversity on September 12, 2002 (the Cartagena Protocol).
Ratification of the Protocol has not resulted in the development and
implementation of a comprehensive biotechnology regulatory framework in
Ukraine. The Ministry of Environment and Nature Protection of Ukraine is
expected to take the lead in the implementation of the Cartagena
Protocol. The Ministry has undergone several reorganizations in the past
few years and changed leadership after the Orange Revolutions. Diverging
interests from other GOU agencies have also been a stumbling block to
the development and implementation of Biosafety Legislation. It is
unclear, at this point, how the new Ukrainian government will implement
the requirements of the Protocol.

# Section IV. Marketing Issues

There are no studies on potential market acceptance related to the sale
of biotechnology products in Ukraine. As consumer incomes in Ukraine
rise, the country is expected to increase imports of processed and
consumer ready food products from the United States and other countries.
Expected enforcement of GMO labeling requirements or possible adoption
of EU labeling and tracebility regulations would have a major negative
impact on both domestic and imported food sales. Consumers in Ukraine
tend to carefully analyze the contents on the label. There is a
widespread belief amongst consumers that products that contain food
additives are not healthy. Therefore, consumers will exercise great
caution in purchasing products with the "GM" mark on the label.

Enforcement of GM labeling of food products will likely harm U.S.
exports of soy-based ingredients used by local meat processors and other
food producers. Feed producers, however, are not going to change their
purchasing decisions as these will likely continue to be determined by
price level and not what's on the label. As part of Ukraine's
commitments under the Cartagena Protocol, documentation requirements for
custom clearance of soybeans or other bulk commodities are expected to
have a greater impact on oilseed processors and feed producers than food
labeling requirements.

Due to frequent regulatory changes in Ukraine, U.S. exporters are
reminded to check with their importers on applicable regulations and
documentation requirements prior to exporting to Ukraine. Interested
exporters may learn more about food and agricultural imports regulations
and standards by downloading the following report prepared by FAS-Kiev
<http://www.fas.usda.gov/gainfiles/200407/146106901.pdf>

# Section V. Capacity Building and Outreach

U.S. government agencies have conducted a number of outreach activities
targeted on creation of an effective and transparent biotechnology
regulatory framework.

FAS-Kiev facilitated an International Seminar on Biosafety in November
2003. Two professors from UC Davis traveled to Ukraine to make
presentations on the U.S. regulatory system and, vertical and horizontal
gene flow. Scientists from Great Britain and Switzerland made
presentations on public debates over GM foods and genomics.
Approximately 50 scientists, graduate students and regulators from
various Ukrainian research institutes and regulatory agencies
representing 20 of the 25 Ukrainian oblasts were present, providing
excellent regional coverage. All presentations from this seminar were
posted on the All-Ukrainian Association of Plant Biologists web site
<http://www.auapb.org/eng/pageseng/5.htm>).

Since the seminar took place well in advance of the final review of the
draft biotech law, scientists from the National Academy of Sciences of
Ukraine had an opportunity to provide comments and suggestions on the
current draft law to the responsible Parliamentary Committees. However,
Parliament's Committee for Science and Education has not made proposed
changes to the draft legislation public before the final voting of the
Law.

In 2002, four Ukrainian scientists from the State Service on Plant
Variety Rights Protection of the Ministry of Agricultural Policy,
Institute of Ecohygiene and Toxicology of the Ministry of Health Care,
Institute of Cell Biology and Genetic Engineering of the National
Academy of Sciences and the Ukrainian Academy of Agricultural Sciences
participated in a two-week training program under the Cochran Fellowship
Program. The program helped to educate key Ukrainian researchers on the
roles played by USDA, Food and Drug Administration and Environmental
Protection Agency in the U.S. coordinated biotechnology regulatory
framework as well as to provide more detailed information on APHIS
biotech regulations.

The Department of State invited two Ukrainian scientists, two regulators
and one journalist on the program entitled "Agricultural Biotechnology
for Sustainable Development" in 2000 under the International Visitors
Program. This was the first opportunity in Ukraine to study the U.S.
biotechnology regulatory system. The trip helped in preparing the
initial draft of Ukraine's biosafety law and provided an excellent
opportunity to initiate a series of well- balanced articles on
agricultural biotechnology
(<http://www.zerkalo-nedeli.com/nn/show/419/36760/>;
<http://www.zerkalo-nedeli.com/nn/show/317/28987/>;
<http://www.zerkalo-nedeli.com/nn/show/372/33134/>). "Dzerkalo Tyzhnya"
Weekly, one of the most reputable Ukrainian newspapers published
articles and also hosted an electronic round table with participation of
scientists from the U.S. Agency for International Development
<http://www.zerkalo-nedeli.com/nn/show/317/28987/>. Articles and the
transcript of the round table are available in Russian.

# Appendices

## 

## Appendix A. The Scheme of Ukraine's Biotechnology Regulatory Process As It Currently Applies to Biotech Crops.

![](media/image3.jpeg){width="5.202083333333333in"
height="6.427083333333333in"}

*Prepared by FAS-Kiev based on available Ukrainian Regulations and
interviews with industry experts.*

## Appendix B. Steps Necessary To Register a Biotech Crop in Ukraine

+---+---+-------------------------------+-----------------------+----+
| * | * | ######## Description          | ######                | ** |
| * | * |                               | ## Responsible Agency | Re |
| P | S |                               |                       | qu |
| h | t |                               |                       | ir |
| a | e |                               |                       | ed |
| s | p |                               |                       | ti |
| e | * |                               |                       | me |
| * | * |                               |                       | ** |
| * |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+
| > | 1 | Application for GMO\'s        | Interagency           | *  |
|   |   | environmental release and     | Commission on         | *2 |
| S |   | registration (The GMO must    | Biosafety (ICB)       | 70 |
| t |   | meet the two following        | (currently under the  | da |
| a |   | criteria: absence of hazard   | Ministry of Science   | ys |
| t |   | for human health and the      | and Education of      | ** |
| e |   | environment (if used as       | Ukraine. According to |    |
| > |   | intended); identifiability)   | the Draft Biosafety   |    |
|   |   |                               | Law, ICB will report  |    |
| R |   |                               | directly to the       |    |
| e |   |                               | Cabinet of Ministers  |    |
| g |   |                               | of Ukraine)           |    |
| i |   |                               |                       |    |
| s |   |                               |                       |    |
| t |   |                               |                       |    |
| r |   |                               |                       |    |
| a |   |                               |                       |    |
| t |   |                               |                       |    |
| i |   |                               |                       |    |
| o |   |                               |                       |    |
| n |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| o |   |                               |                       |    |
| f |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| t |   |                               |                       |    |
| h |   |                               |                       |    |
| e |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| G |   |                               |                       |    |
| M |   |                               |                       |    |
| O |   |                               |                       |    |
| . |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+
|   | 2 | The ICB conducts              | ICB                   |    |
|   |   | environmental risk            |                       |    |
|   |   | assessments and issues one of |                       |    |
|   |   | three possible verdicts:      |                       |    |
|   |   |                               |                       |    |
|   |   | a\. - release of the GMOs     |                       |    |
|   |   | into the environment is safe; |                       |    |
|   |   |                               |                       |    |
|   |   | b\. - release of the GMOs     |                       |    |
|   |   | into the environment is safe  |                       |    |
|   |   | subject to specific           |                       |    |
|   |   | requirements;                 |                       |    |
|   |   |                               |                       |    |
|   |   | c\. - release of the GMO into |                       |    |
|   |   | the environment is            |                       |    |
|   |   | potentially unsafe            |                       |    |
+---+---+-------------------------------+-----------------------+----+
|   | 3 | The GMOs that received a or   | ICB, Ministry of      |    |
|   |   | b-type verdicts (step #2) are | Education and Science |    |
|   |   | to be included into the State |                       |    |
|   |   | Register of the GMOs\*.       |                       |    |
+---+---+-------------------------------+-----------------------+----+
| > | 4 | Application to import GMP     | State Service for     | *  |
|   |   | plants for variety testing    | Plant Varieties       | *U |
| I |   |                               | Rights Protection     | nk |
| m |   |                               | under the Ministry of | no |
| p |   |                               | Agricultural Policy   | wn |
| o |   |                               | of Ukraine            | ** |
| r |   |                               | (SSPVRP/MAPU)         |    |
| t |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| P |   |                               |                       |    |
| e |   |                               |                       |    |
| r |   |                               |                       |    |
| m |   |                               |                       |    |
| i |   |                               |                       |    |
| t |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| f |   |                               |                       |    |
| o |   |                               |                       |    |
| r |   |                               |                       |    |
| > |   |                               |                       |    |
|   |   |                               |                       |    |
| T |   |                               |                       |    |
| e |   |                               |                       |    |
| s |   |                               |                       |    |
| t |   |                               |                       |    |
| i |   |                               |                       |    |
| n |   |                               |                       |    |
| g |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+
|   | 5 | Application is forwarded for  | Institute of          | *  |
|   |   | an examination                | Agricultural Ecology  | *U |
|   |   |                               | and Biotechnology,    | nk |
|   |   |                               | Ukrainian Academy of  | no |
|   |   |                               | Agricultural Sciences | wn |
|   |   |                               |                       | ** |
+---+---+-------------------------------+-----------------------+----+
|   | 6 | Supporting letter is sent to  | Interagency Council   | *  |
|   |   | the Ministry of Agricultural  | on Regulation of      | *U |
|   |   | Policy                        | Testing, Registration | nk |
|   |   |                               | and Usage of          | no |
|   |   |                               | Transgenic Plant      | wn |
|   |   |                               | Varieties of the      | ** |
|   |   |                               | SSPVRP/MAPU           |    |
+---+---+-------------------------------+-----------------------+----+
|   | 7 | Import permit for testing is  | Ministry of           | ** |
|   |   | issued                        | Agricultural Policy   | 30 |
|   |   |                               | of Ukraine            | ** |
+---+---+-------------------------------+-----------------------+----+
| > | 8 | Usual State Plant Variety     | SSPVRP/MAPU           | *  |
|   |   | Testing Program under control |                       | *2 |
| T |   | of the Interagency Council on |                       | -3 |
| e |   | Regulation of Testing,        |                       | y  |
| s |   | Registration and Usage of     |                       | ea |
| t |   | Transgenic Plant Varieties    |                       | rs |
| i |   |                               |                       | ** |
| n |   |                               |                       |    |
| g |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+
|   | 9 | GM samples are sent for a     | Nutrition Research    | *  |
|   |   | food safety assessment        | Institute under the   | *U |
|   |   |                               | Ministry of Health    | nk |
|   |   |                               | Care of Ukraine       | no |
|   |   |                               |                       | wn |
|   |   |                               |                       | ** |
+---+---+-------------------------------+-----------------------+----+
|   | 1 | Approval of the GM variety    | Interagency Council   | *  |
|   | 0 | subject to favorable test     | on Regulation of      | *U |
|   |   | results (steps 9-10)          | Testing, Registration | nk |
|   |   |                               | and Usage of          | no |
|   |   |                               | Transgenic Plant      | wn |
|   |   |                               | Varieties of the      | ** |
|   |   |                               | SSPVRP/MAPU           |    |
+---+---+-------------------------------+-----------------------+----+
| > | 1 | Entry of the GM plant variety | SSPVRP/MAPU           | *  |
|   | 1 | into the State Register of    |                       | *U |
| F |   | Plant Varieties of Ukraine    |                       | nk |
| i |   |                               |                       | no |
| n |   | Note: Although, GM plant      |                       | wn |
| a |   | variety testing is to be      |                       | ** |
| l |   | conducted the same way as for |                       |    |
| > |   | conventional varieties, GM    |                       |    |
|   |   | varieties have to be included |                       |    |
| p |   | into a separate section of    |                       |    |
| e |   | the State Plant Varieties     |                       |    |
| r |   | Register                      |                       |    |
| m |   |                               |                       |    |
| i |   |                               |                       |    |
| t |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+
| # |   |                               |                       | *  |
| # |   |                               |                       | *3 |
| # |   |                               |                       | -4 |
| # |   |                               |                       | y  |
| # |   |                               |                       | ea |
| # |   |                               |                       | rs |
| # |   |                               |                       | ** |
| # |   |                               |                       |    |
|   |   |                               |                       |    |
| E |   |                               |                       |    |
| s |   |                               |                       |    |
| t |   |                               |                       |    |
| i |   |                               |                       |    |
| m |   |                               |                       |    |
| a |   |                               |                       |    |
| t |   |                               |                       |    |
| e |   |                               |                       |    |
| d |   |                               |                       |    |
|   |   |                               |                       |    |
| m |   |                               |                       |    |
| i |   |                               |                       |    |
| n |   |                               |                       |    |
| i |   |                               |                       |    |
| m |   |                               |                       |    |
| u |   |                               |                       |    |
| m |   |                               |                       |    |
|   |   |                               |                       |    |
| t |   |                               |                       |    |
| i |   |                               |                       |    |
| m |   |                               |                       |    |
| e |   |                               |                       |    |
|   |   |                               |                       |    |
| r |   |                               |                       |    |
| e |   |                               |                       |    |
| q |   |                               |                       |    |
| u |   |                               |                       |    |
| i |   |                               |                       |    |
| r |   |                               |                       |    |
| e |   |                               |                       |    |
| d |   |                               |                       |    |
|   |   |                               |                       |    |
+---+---+-------------------------------+-----------------------+----+

\* Presidential Degree established Interagency Commission on Biological
and Genetic Safety under the National Security Council of Ukraine on
06/23/2004. It is yet another advisory body responsible for biosafety
issues. It is expected, however, that this Commission will pay more
attention to bioterrorism-related problems.

## Appendix C. Agency Responsibilities As Per the Draft Law of Ukraine "On the State Biosafety System for Development, Testing and Usage of Genetically Modified Organisms".

***Interagency Biosafety Commission***

\- promote implementation of state policy in the area of safe usage of
the GMOs;

\- provide advice to central executive agencies, entities involved in
genetic engineering and public organizations on safe use of the GMOs;

\- coordinate the actions of central executive agencies and scientific
institutions in the area of safe use of GMOs;

\- draft regulations on genetic engineering in accordance with the
development of scientific knowledge and develop proposals on improving
existing regulations;

\- develop criteria for assessing the risk of potential environmental
impact of GMOs;

\- develop and improve a system of controlling compliance with genetic
engineering safety requirements;

\- consider applications for the release of GMOs into the environment by
examining documents submitted by the applicant and engaging institutions
authorized by the commission in such examination;

\- organize, if necessary, limited pre-registration testing of GMOs by
institutions authorized by the commission;

\- issue conclusions as to the possibility of release and registration
of GMOs;

\- ensure control over safety of genetic engineering and during release
of GMOs into the environment;

\- perform registration of genetic engineering works of risk levels 3
and 4

\- inform the public about genetic engineering activities performed in
Ukraine and biosafety measures that are in place;

\- participate via other government agencies in cooperation with
international organizations.

***Ministry of Environment and Nature Protection***

\- environmental risk assessment of GMOs via its representatives in the
Interagency Biosafety Commission under the Cabinet of Ministers of
Ukraine;

\- exercise state supervision and control over the practical use of
GMOs;

\- carry out long-term monitoring of the potential impact of GMOs to the
environment;

\- exercise control over biosafety measures during GMO testing;

\- information dissemination, education and participation of the public
in ensuring sustainable use of biological diversity;

\- within its powers, issue regulations necessary to ensure enforcement
of this Law.

***Ministry of Health Care of Ukraine***

\- perform state sanitary and hygienic examination and registration of
foodstuffs, biologically active food supplements, cosmetic and
pharmaceutical products and other products intended for direct human
consumption, which contain GMOs.

\- perform necessary tests of GMOs used in the production of foodstuffs,
biologically active food supplements, cosmetic, pharmaceutical products
and other products in order to ensure protection of human health;

***Ministry of Agricultural Policy***

\- ensure state testing and registration of GMO-based crop varieties,
animal breeds, microbiological agricultural and veterinary preparations
and crop protection means via its agencies;

-   ensure control over compliance with safety requirements when
    performing genetic engineering activities in agricultural
    enterprises, institutions and organisations irrespective of
    subordination and ownership;

> ***Ministry of Science and Education***

\- develop research potential in the area of genetic engineering;

-   registers the GMO and maintains a special GMO register.

-   Protects national and international patents in the area of genetic
    engineering.