Required Report - public distribution

**Date:** 7/7/2006

**GAIN Report Number:** HU6008

HU6008

**Hungary**

**Biotechnology**

**Annual Report**

**2006**

**Approved by:**

![](media/image1.wmf)Sarah Hanson

U.S Embassy

**Prepared by:**

Dr. Ferenc Nemes

**Report Highlights:**

Hungary's biotechnology policy for feed corn production, corn seed
production, and soybean product (soybean meal) imports negatively
impacts U.S. exports to Hungary. Field corn and seed corn production
(about one fifth of the EU's corn crop) is dominated by American
varieties. Four biotech varieties passed the evaluation process and are
waiting approval, two others are still under field trials. The
Government of Hungary (GOH) sent a draft of its coexistence regulation
to the European Commission for approval on October 15, 2005. The
Commission sent back its detailed opinion on the draft in March 2006.
The GOH plans to send its response to the Commission during the summer
of 2006, and the revised draft may be presented to the Hungarian
Parliament for debate this fall. Legal and technical debates about the
coexistence regulation may hamper the commercialization of biotechnology
crop varieties in Hungary over the next few years.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[HU\]

> **Executive summary**

Hungary's biotechnology policy for feed corn production, corn seed
production, and soybean product (soybean meal) imports negatively
impacts U.S. exports to Hungary. Field corn and seed corn production
(about one fifth of the EU's corn crop) is dominated by American
varieties. Four corn varieties passed the evaluation process and are
waiting approval, two others are still under field trials. The
Government of Hungary (GOH) sent a draft of its coexistence regulation
to the European Commission for approval on October 15, 2005. The
Commission sent back its detailed opinion on the draft in March 2006.
The GOH plans to send its response to the Commission during the summer
of 2006, and the revised draft may be presented to the Hungarian
Parliament for debate this fall. Legal and technical debates about the
coexistence regulation may hamper the commercialization of biotechnology
crop varieties in Hungary over the next few years.

> **Biotechnology Trade and Production\--Status of Product Approvals**
>
> No biotechnology crop varieties are produced in Hungary. Three
> varieties have gone through field trials and are waiting registration,
> including:
>
> Field trials finished in 2003:
>
> MEB 470 BT (DK 440 BTY) MON 810 code number corn borer resistant
> (MONSANTO)
>
> NX 3035 (Alpha BT) Bt11 code number corn borer resistant (Syngenta)
>
> X 0987ZT MON 810 code number corn borer resistant (Pioneer Hi-Bred
> Rt.)
>
> The Ministry of Agriculture and Rural Development (MARD) refused to
> approve the registration of the above varieties because coexistence
> regulation is not yet in place.
>
> Additional corn varieties subject to field trials include:
>
> MEB 471 RR (DK 440 RR) NK603 code number Roundup Ready tolerant
> (MONSANTO)
>
> MEB 391 RR (DK 391 RR) NK603 code number Roundup Ready tolerant
> (MONSANTO)
>
> X1019VT BT code number corn borer resistant (PIONEER Hi-Bred Rt.)
>
> On January 20, 2005, the Government of Hungary (GOH) imposed a
> moratorium on corn varieties containing the MON 810 event. The
> moratorium went into effect by a Minister's Decree, and the legal
> paperwork for the moratorium is now in Brussels for official review.
> According to MARD sources, the response of the Commission on the ban
> is expected in the summer of 2006.
>
> The four main reasons for the moratorium were the following:
>
> 1). The negative results of an environment effect study. The research
> carried out in Hungary under the direction of the Plant Protection
> Institute of the Hungarian Academy of Sciences focused on genetically
> modified maize DK 440 BTY containing the genetic construction
> YieldGardTM MON 810. Laboratory and small-scale parcel field
> experiments showed that the long-term presence of the plant might have
> adverse effects on the ecosystem. (*Darvas et al. (2003)* [EFFECT OF
> POLLEN OF DK-440-BTY (YIELDGARD) BT MAIZE ON THE LARVAE OF *INACHIS
> IO* L. (NYMPHALIDAE)]{.underline} Hungarian Academy of Sciences, Plant
> Protection Institute, Ecotoxicology Department, Budapest)
>
> 2). The need to repeat the late 1990s EU trials using contemporary
> methodology for this event.
>
> 3). The specific ecological conditions of the " Pannonian
> biogeographic region" (a region containing parts of Hungary, Austria,
> and Slovenia) questions the validity of risk assessment based on the
> ecosystems of the older Member States, owing to its different
> environmental features.
>
> 4). Hungary has no coexistence regulation yet.
>
> Hungary is an active participant in the development of biotechnology
> crops at the basic science level, as well as in the research of the
> environmental, feeding, etc. effects of these crops in cooperation
> with other countries.
>
> Hungary does not import biotechnology crops, but imports soybean meal,
> peanut butter, sauces and other products containing biotech raw
> materials.
>
> **Biotechnology Policy\--Regulatory Framework**
>
> In the case of green (agricultural) biotechnology, the MARD takes the
> lead concerning the cultivation, importation, and processing into
> food/feed. The Hungarian Food Safety Authority (HFSA) under the
> Ministry of Health (MH) is the top umbrella organization, but most of
> the administrative responsibilities and the institutional background
> belong to the MARD. The Ministry of Environment and Water Management
> (MEW) handles certain biotechnology regulation portfolios and also
> participates in the work of the Biotechnology Committee (BC). MH is
> responsible for the red biotechnology (medicinal use), and the
> Ministry of Economy and Transport (MET) handles foreign trade and
> strategic investment affairs. Both the MH and the MET are advocates of
> biotechnology as the key to further economic development but firmly
> differentiate between red (thought of positively) and green (thought
> questionably) biotechnology.
>
> The Biotechnology Committee (BC) has a key role in evaluating the
> applications (new varieties, genes, etc.) although the approval is
> formally made by the MARD. The Hungarian Academy of Science (MTA) may
> delegate five members, the relevant Ministries (MARD, MET, MH, MEW)
> and the Ministry of Education delegate one each, and NGOs may nominate
> seven delegates (including one by the pro-biotech Zoltan Barabas
> Biotechnology Association) to the 17 member BC. Civil Servants
> (government employees) are not members of the BC. Ministries nominate
> scientists or experts from 'think tanks' belonging to their
> Department. The "independent" BC sets its own rules, supposing that
> the question is not regulated in the Act No. XXVII. of 1998 On
> Biotechnology or elsewhere (e.g. 111/2003. (XI.5.) Order of Ministers
> of MARD, MET, MH, and MEW on Genetic Modification and Like Processes,
> and their Inspection Authorities).
>
> Administrative and service charges of the Committee and other
> authorities inspecting biotechnology experiments are set in the
> 138/2004. (IX.23) [Order of the Minister of MARD]{.underline} o[n the
> administrative and Service Fees for the Approval of Gene-technology
> Activities.]{.underline}
>
> Regulatory decisions may be influenced by different political factors,
> including:
>
> \- EU market orientation of Hungary's corn and corn seed production.
> Traditionally strong cooperation with Austria and Germany, main
> opponents of GMOs.
>
> \- The Hungarian consumer is pragmatic, but domestic and international
> green organizations are increasingly active in Hungary.
>
> \- Politicians, government officers, journalists and sometimes
> scientists are shy to express their opinions about biotechnology or
> even participate in topical seminars.
>
> **Biotechnology Research**
>
> Besides testing biotechnology crop varieties, Hungarian biotechnology
> laboratories are dealing with the analysis of different GMO materials.
> Use of these biotechnology materials (for variety field test or any
> other feeding, environmental effect, etc. trials) must also be
> approved by the BC. According to a BC decision, stacked events are
> taken for new events, considering possible cross effects. Lists of
> biotechnology materials and programs are available at the website of
> the Godollo Agricultural Biotechnology Center
> ([www.abc.hu]{.underline}) and the website of the EU Commission,
> Directorate General, Joint Research Centre (http://biotech.jrc.it)
> quoted in ANNEX I.
>
> Researchers of the "Pannonian Region" countries (see page 2, point 3)
> established the "Pannonian Region Agricultural Biotechnology
> Association" in June 2006. The partnership of respected scientists and
> plant breeding and seed business entities from Austria, Czech
> Republic, Hungary, Slovakia, Slovenia, Romania, Croatia,
> Bosnia-Hercegovina, Serbia, and Ukraine plan to facilitate regional
> collaboration, information exchange, and to assist country based
> biotechnology efforts.
>
> **Coexistence Regulation**
>
> The MARD finished the drafting and first panel discussions of the
> Hungarian coexistence regulation in June 2005. The draft was sent for
> Commission approval on October 15, 2005. The drafting period (first
> half of 2005) included vivid discussions at different government and
> NGO forums. Representatives of the biotechnology industry and the
> Biotechnology Association participated in the work of the Coexistence
> Working Committee.
>
> The Commission sent back its detailed opinion on the draft to the MARD
> in March 2006. The Commission's opinion proposed corrections in the
> draft coexistence regulation.
>
> \- In some instances (i.e. the ban of EU listed varieties and the
> request for further environmental risk assessments) the GOH wants to
> regulate issues that are harmonized at the EU level.
>
> \- In the case of producer liability, the Commission stressed that
> measures, including liability rules must be proportionate with the
> objectives and potential risks.
>
> The GOH plans to send back to the Commission its response during the
> summer of 2006. The revised draft may be presented to the Hungarian
> Parliament for debate this fall.
>
> The Biotchnology Association, the main lobbying organization of the
> biotechnology industry, is dissatisfied with the draft. The least
> acceptable points of the coexistence regulation for the industry are
> the isolation distances and the required neighbor farmer (landowner)
> permits. The isolation distance set by the draft for corn is 400
> meter, more than double of the distance used in hybrid seed
> propagation worldwide. Written permit from the neighbor farmer, prior
> to the application of the GMO variety, is also not necessary in civil
> liability (as the Commission has indicated). These requirements may
> "de facto" block the commercialization of biotechnology varieties.
>
> **Labeling rules**
>
> Act No LXXXII of 2003 on Food (AF) is a general, "umbrella" piece of
> legislation. The Act does not contain the domestic versions of EU
> (European Council or Commission) directives, so it does not need to be
> revised whenever any EU directive is changed. The domestic directives
> are contained in the **Hungarian Food Codex (HFC)** or other separate
> legal rules (such as legislation for Wine, for Mineral Water, and for
> Meat and Meat Products). General prescriptions of the Act must be
> applied together with HFC directives and other corresponding
> regulations.
>
> All kinds of food, including food imported for commercial sale, fall
> under the ruling of the Act. (Products from other EU member countries
> are considered as domestic products (§7. (2)) See the AF in English at
> [http://www.fvm.hu/files/elelmiszeripar/elszi_5_en.pdf]{.underline}
>
> Other corresponding regulations include:
>
> **19/2004. (Feb 26.) Order of the Min of Agr-Min of Health-Min of
> Economy [On labeling of Foodstuffs]{.underline}**
>
> **138/2004 (Sep 23.) Order of the Min of Agriculture** **[On the
> administrative and Service Fees for the Approval of Gene-technology
> Activities]{.underline}**
>
> e.g. -Fees for the approval of commercial sales of GMOs and products
> thereof
>
> -Fees for the approval of the export-import trade of above products
>
> **142/2004. (Sep 30.) Order of Min of Agr-Min of Economy** **[On Some
> Rules of Gene-technology Activities in Agriculture and
> Industry]{.underline}**
>
> e.g. Labeling of products containing GMOs (above the threshold level).
>
> Hungary is not an importer of biotech products, excluding animal feed.
> Plant propagation materials (seeds) go through systematic sampling and
> laboratory analyses. However, for feed and food, where the exporter
> must declare the quality of the product, only random sampling takes
> place.
>
> The accredited laboratory for biotechnology testing is the Biomi Kft.,
> a joint venture between the Agricultural Biotechnology Center at
> Godollo and the Dr. E. Wessling Chemical Laboratory Kft.
> (www.biomi.hu)
>
> **Cartagena Biosafety Framework**
>
> Hungary has ratified the Biosafety Protocol. The legislation is the
> CIX./2004. Act on the Promulgation of the Cartagena Protocol on
> Biosafety to the Convention on Biological Diversity. The
> implementation rules of the Act have not yet been prepared.
>
> **Capacity Building and Outreach**
>
> Post has sponsored government officers, scientists and journalists on
> agricultural biotechnology programs in the US through the Cochran
> Fellowship Program over the past few years.
>
> The International Visitor Program of State Department has also been
> used for sending a Hungarian government official to the United States
> as part of an outreach activity.
>
> In 2005, the USDA/FAS Biotechnology unit co-sponsored the travel of a
> Hungarian journalist to participate at the congress of the
> International Service for the Acquisition of Agri-biotech Applications
> (ISAAA) in Singapore, March 18-24, 2005. The goal of the Hungarian
> participation was to facilitate the establishment of a Hungarian
> 'node', a national knowledge center, of the ISAAA.
>
> **ANNEX**
>
> I. Deliberate releases, Plants -- Hungary, 2006
>
> ![](media/image2.wmf){width="1.0in" height="0.25in"}

+-----------+-----+--------+----------+-------------------------+----+
| > **Not   | >   | >      | > **Name | > **Project title**     | *  |
| ification | **S | **Pub. | > of the |                         | *F |
| >         | tat | >      | > In     |                         | in |
|  number** | e** | Date** | stitutes |                         | al |
|           |     |        | > or     |                         | re |
|           |     |        | > Com    |                         | po |
|           |     |        | panies** |                         | rt |
|           |     |        |          |                         | ** |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 21/0 | > St.    | > Field trials program  |    |
| B/HU/06/0 | ung | 3/2006 | >        | > of maize varieties    |    |
| 2/3]{.und | ary |        |  Stephen | > resistant to certain  |    |
| erline}** |     |        | > Un     | > Coleopteran insects   |    |
|           |     |        | iversity | > and tolerant to a     |    |
|           |     |        |          | > herbicide (59122      |    |
|           |     |        |          | > maize)                |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 10/0 | > St.    | > Field trials program  |    |
| B/HU/06/0 | ung | 3/2006 | >        | > of genetically        |    |
| 2/4]{.und | ary |        |  Stephen | > modified maize        |    |
| erline}** |     |        | > Un     | > resistant to certain  |    |
|           |     |        | iversity | > Coleopteran insects   |    |
|           |     |        |          | > and tolerant to two   |    |
|           |     |        |          | > herbicides            |    |
|           |     |        |          | > (59122xNK603 maize)   |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 10/0 | > St.    | > Field trial program   |    |
| B/HU/06/0 | ung | 3/2006 | >        | > of genetically        |    |
| 2/5]{.und | ary |        |  Stephen | > modified maize        |    |
| erline}** |     |        | > Un     | > resistant to certain  |    |
|           |     |        | iversity | > Lepidopteran and      |    |
|           |     |        |          | > Coleopteran insects   |    |
|           |     |        |          | > and tolerant to two   |    |
|           |     |        |          | > herbicides            |    |
|           |     |        |          | > (59122x1507xNK603     |    |
|           |     |        |          | > maize)                |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 10/0 | > St.    | > Field trial program   |    |
| B/HU/06/0 | ung | 3/2006 | >        | > of genetically        |    |
| 2/1]{.und | ary |        |  Stephen | > modified maize        |    |
| erline}** |     |        | > Un     | > varieties resistant   |    |
|           |     |        | iversity | > to certain            |    |
|           |     |        |          | > Lepidopteran and      |    |
|           |     |        |          | > Coleopteran insects   |    |
|           |     |        |          | > and tolerant to       |    |
|           |     |        |          | > glufosinate-ammonium  |    |
|           |     |        |          | > herbicide (1507x59122 |    |
|           |     |        |          | > maize)                |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 10/0 | > St.    | > Field trial program   |    |
| B/HU/06/0 | ung | 3/2006 | >        | > of genetically        |    |
| 2/2]{.und | ary |        |  Stephen | > modified maize        |    |
| erline}** |     |        | > Un     | > varieties resistant   |    |
|           |     |        | iversity | > to certain            |    |
|           |     |        |          | > Lepidopteran insects  |    |
|           |     |        |          | > and tolerant to two   |    |
|           |     |        |          | > herbicides            |    |
|           |     |        |          | > (1507xNK603 maize)    |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 07/0 | > Dow    | > Field trial program   |    |
| B/HU/05/1 | ung | 3/2006 | > Agro   | > of genetically        |    |
| 2/1]{.und | ary |        | Sciences | > modified corn hybrids |    |
| erline}** |     |        | >        | > containing resistance |    |
|           |     |        |  Hungary | > to certain            |    |
|           |     |        | > Kft.   | > Lepidopteran insects  |    |
|           |     |        |          | > and tolerance to two  |    |
|           |     |        |          | > herbicides.           |    |
+-----------+-----+--------+----------+-------------------------+----+
| > **[     | > H | > 07/0 | > Dow    | > Field trial program   |    |
| B/HU/05/1 | ung | 3/2006 | > Agro   | > of genetically        |    |
| 2/2]{.und | ary |        | Sciences | > modified corn hybrids |    |
| erline}** |     |        | >        | > containing resistance |    |
|           |     |        |  Hungary | > to certain            |    |
|           |     |        | > Kft.   | > Coleopteran and       |    |
|           |     |        |          | > Lepidopteran insects  |    |
|           |     |        |          | > and tolerance to two  |    |
|           |     |        |          | > herbicides.           |    |
+-----------+-----+--------+----------+-------------------------+----+