Required Report - public distribution

**Date:** 7/8/2005

**GAIN Report Number:** RO5008

RO5008

**Romania**

**Biotechnology**

**Annual**

**2005**

**Approved by:**

![](media/image1.wmf)Brian Goggin

U.S. Embassy Bucharest

**Prepared by:**

Cristina Cionga

**Report Highlights:**

Romanian's role as a biotech promoter is clearly in jeopardy, despite
the continued support from farmers, and a core group of pro-biotech GOR
officials. Local subsidiaries of seed companies have committed to GOR
regulators, to meet or in some cases exceed Romania's regulatory
requirements, in order to maintain their position on the Romanian
market. Given the pressure from the EU, and Romania's weakened
bargaining position, this compliance may not be enough to salvage GMO
cultivation in Romania.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Sofia \[BU1\]

\[RO\]

Table of Contents

[I. EXECUTIVE SUMMARY 3](#i.-executive-summary)

[II. BIOTECHNOLOGY TRADE AND PRODUCTION
3](#ii.-biotechnology-trade-and-production)

[III. BIOTECHNOLOGY POLICY 3](#iii.-biotechnology-policy)

[The National Authority for Biotech-related Issues
4](#the-national-authority-for-biotech-related-issues)

[Approval Procedures 4](#approval-procedures)

[Monitoring and Enforcement 4](#monitoring-and-enforcement)

[Labeling 5](#labeling)

[Traceability 5](#traceability)

[Testing 6](#testing)

[Table of Approved Biotechnology Products in Romania (2005)
6](#table-of-approved-biotechnology-products-in-romania-2005)

[Notification Dossier 6](#notification-dossier)

[Co-existence 7](#co-existence)

[Rules Governing the Movement and International Trade of Transgenic
Products
7](#rules-governing-the-movement-and-international-trade-of-transgenic-products)

[Trade Barriers 8](#trade-barriers)

[Intellectual Property Rights 8](#intellectual-property-rights)

[IV. MARKETING ISSUES 8](#iv.-marketing-issues)

[V. CAPACITY BUILDING AND OUTREACH
8](#v.-capacity-building-and-outreach)

# I. EXECUTIVE SUMMARY

# 

Invoking pressure from the EU and Romania's weakened bargaining
position, GOR representatives recently indicated that the permit for
commercial cultivation of herbicide resistant soybeans in Romania is in
jeopardy for the 2006 crop year, despite the obvious economic and
environmental advantages of the technology. There is an informed and
positive opinion among growers regarding biotech soybeans. In MY2004/05,
roughly 50,000 hectares of biotech soybeans led to record yields and for
the first time Romania turned into a net exporter of vegetable protein
that soybeans provide.

AgBucharest has constantly made the argument that, in order to be
successful, Romania\'s government must step up with additional resources
to properly regulate the crop in a way that meets the EU requirements.
Romania has shown that it can successfully grow, process and market
products of agricultural biotechnology that are as safe as any
conventionally produced crops, but still needs to improve their
regulatory controls.

# II. BIOTECHNOLOGY TRADE AND PRODUCTION

Since 2000, Romania, which is expected to join the European Union in
2007, has pioneered the planting of biotech crops, especially soybeans.
The first approval for commercial planting of GM soybeans (Glycine max.
line GTS 40-3-2) tolerant to glufosinate herbicide was issued by the
Romanian Biosafety Commission in accordance with the GOR Ordinance
49/2000.

In 2001, about 15,000 hectares of biotech soybeans were planted and the
figure steadily climbed as farmers saw the advantages of the new
technology, especially given Romania's huge weed reserve. In 2004,
roughly 50,000 hectares of biotech soybeans led to record yields, while
the local affiliates of US biotech companies reported unprecedented high
demand for seeds for the just completed 2005 spring campaign. Growers
are well aware that they can benefit by continuing to produce GM
soybeans, as there is a great protein deficit in the EU.

In recent years, field trials were approved for a number of genetically
engineered crops, including BT potato, sugar beet, and corn. In 2005,
variety testing is being conducted in the national network for a
herbicide-resistant corn hybrid (NK603).

## 

# III. BIOTECHNOLOGY POLICY

GOR efforts to bring its regulatory capacity into line with EU rules and
international agreements resulted in the passage of Law 214 of April 19,
2002, effective from May 2002, which enforces and amends GOR Ordinance
49/2000 on obtaining, testing, utilization, and commercialization of
GMOs, as well as products derived from GMOs. The Law provides the main
framework for bio-engineered products in Romania. Two other pieces of
legislation relevant to biotech-related issues are: (1) GOR Decision
106/February 2002 on labeling food derived from GMOs, or containing
genetically modified additives and (2) Minister of Agriculture's Order
462/2003, effective from July 2003, with provisions aimed at tracing
biotech products.

By the end of 2005, in accordance with its EU accession commitments,
Romania should adopt the new legislation on traceability and labeling of
food products deriving from GMOs.

## The National Authority for Biotech-related Issues

According to Law 214/2002, the competent authorities in implementing and
enforcing all activities related to the use of GMOs, and all activities
concerning the deliberate release of GMOs are: (1) the Ministry for
Environment and Water Management, responsible for the issuance of
authorizations/permits and carrying out the post-control of all related
activities (the National Authority, NA); (2) the Ministry of
Agriculture, Forests and Rural Development; (3) The Ministry of Health
and Family; (4) the National Authority for Consumer Protection.

Additionally, the National Biosafety Commission (NBC), an independent
scientific body, advises the Ministry of Environment during the decision
making process on biotech policy. The NBC consists of twelve scientists
with relevant backgrounds who are members of the Romanian Academy or
representatives of research institutes in life sciences, agriculture or
medicine.

## Approval Procedures

Law 214/2002 stipulates that, the user shall submit to the National
Authority, prior to the utilization of any GMO, notification containing
at least the information specified by Law 214 (see below). After
receiving the notification, the NA will inform and consult with the
public regarding the received notification and consult the Biosafety
Commission, which will then evaluate the environmental and agricultural
impact of such use. The NA will then also request specific assessments
from the Ministry of Health and the National Authority for Consumer
Protection (which is responsible for food and feed safety) on the
impacts of such use on human health.

The NA (the Ministry of Environment and Water Management) must respond
to the notifier within a period of 90 days after receipt of the
notification whether or not the received notification is in compliance
with the current legislation. The notifier may be required to submit
additional information. If the proposed activity does not comply with
the legislation in effect, the notification is rejected. The 90-day
period referred to does not include any periods of time during which the
NA: (a) is awaiting further information requested from the notifier, (b)
is awaiting the approval of the Biosafety Commission; (c) is conducting
public hearings. If the National Authority considers that sufficient
evidence has already been gathered through the previous release of
certain genetically modified organisms into the environment, it can
decide to apply simplified approval procedures. The notifier may proceed
with the proposed activity only after obtaining the NA authorization,
and it must observe the conditions specified in the authorization.
In-country field tests are required prior to granting the commercial
status to biotech crops.

## Monitoring and Enforcement

According Law 214/2002, the NA officially issues the approval for
releasing a specified genetically modified organism into the
environment, while relevant departments are responsible for assessing
different types of risk conduct post-approval surveillance to check
compliance with authorization requirements.

Violations of Law 214/2002 provisions may become infringements according
to the penal law and they are punished with a fine (from approximately
\$300 to \$3000 at the current exchange rate) and/or temporary or final
suspension of the activity, on a case by case basis. Specialized
personnel authorized by the Ministry Agriculture, Waters, Forests and
Environment, Ministry of Public Health and Family and the National
Authority for Consumer Protection enforce the sanctions provided by the
law. Law 214/2002 also states that if damage results from activities
regulated through this law that is detrimental to human or animal
health, to biological diversity or to the environment, the user is
responsible for the damage. The nature and scope of the damage are to be
established by a commission of experts appointed by the National
Authority.

## Labeling

According to Law 214/2002, the producer is responsible for labeling
biotech products placed on the market. This complies with EU legislation
and regulations 1/39/98, 49/2000, and 50/2000. The notification
submitted to the NA requires the applicant to provide a description of
the envisaged conditions for placing the product on the market,
including use, handling, and a proposal for labeling and packaging which
should comply with the requirements stipulated by Law 214/2002. The
label shall clearly state if the genetically modified organism is
present. The label bearing the inscription "This product contains
genetically modified organisms" is compulsory. There is currently no law
or regulation governing the use of labels such as biotech-free,
non-biotech, GMO-free, or non-GMO, Law 214/2002 states that within a
period of 10 years procedures for such labeling will be established.

The GOR Decision 106/February 2002 - further detailed in its
accompanying Methodological Norm 7/2002 - provides more detail on the
labeling methodology of foods obtained from biotechnology or containing
genetically modified additives derived from GMOs. Interestingly, this
norm is narrowed to foodstuffs delivered as such to the final consumer
and to processed food entirely or partially obtained from: (i)
genetically modified soybean and/or (ii) genetically modified corn.
"Product derived from GM Soybean" or "product derived from GM corn" must
be clearly written on the label. These additional labeling requirements
can be ignored if the content of biotech soybean or corn is less than 1
percent of total ingredients.

## Traceability

Tracking biotech products in Romania has become stricter and more
rigorous lately from the regulatory perspective. Traceability is
required as a consequence of the labeling requirements provided by Law
214/2002 and GOR Decision 106/2002, brought in line EU directives.

In July 2003, the Minister of Agriculture, Waters, Forests and
Environment issued its Order 462 which requires all farmers using seeds
for biotech crops to report the area planted with such seeds and the
yields obtained. More specifically, all individuals/companies that
cultivate biotech crops must submit two declarations to the Directorate
for Agriculture and Rural Development of the Ministry of Agriculture,
Waters, Forests and Environment, the first one within 10 days after
sowing is completed, while the second one within 10 days after harvest.
The first declaration must describe the name of the crop, area
cultivated, and the origin of the seed (whether acquired via procurement
or own production). The second declaration must include the name of the
plant, the production obtained and its destination (seed for sowing or
consumption).

The regulation on traceability requires companies involved in this
business, when using or handling biotech products, to submit and keep
information at each stage of placing them on the market. Companies are
responsible for ensuring that a tracking system is in place.

## Testing

Prior to being accepted for commercial cultivation and use (food,
processing and feed), any transgenic variety should be first approved
for experimental environmental release (field trials). Currently, there
is only one corn hybrid, tolerant to glyphosate herbicide (NK603),
approved for testing on about 1 HA in the network of the State Institute
for Variety Trials and Registration (ISTIS).

**Commercially approved transformation events** are being reauthorized
for testing every year, even in the particular case of hybrid/variety
registration tests carried out by the State Institute for Variety Trials
and Registration. Required paperwork of the notifier is extremely
time-consuming in this respect, as the NA calls for all regulatory
agencies' re-issuance of approvals, including the ones with multiyear
validity (e.g, Ministry of Health's case).

### 

### 

###  Table of Approved Biotechnology Products in Romania (2005)

+-------------+----------+-----------+---------+----------+----------+
| **Crop**    | **Trait  | **Appli   | **      | **Trait  | **       |
|             | Ca       | cant(s)** | Event** | Descr    | Approved |
|             | tegory** |           |         | iption** | for**    |
+-------------+----------+-----------+---------+----------+----------+
| Soybe       | H        | Monsanto, | GTS     | Glu      | Field    |
| ans/Glycine | erbicide | Pioneer   | 40-3-2  | fosinate | Trials;  |
| max.        | T        |           |         | tolerant |          |
|             | olerance |           |         |          | co       |
|             |          |           |         |          | mmercial |
|             |          |           |         |          | cul      |
|             |          |           |         |          | tivation |
|             |          |           |         |          | and      |
|             |          |           |         |          | pr       |
|             |          |           |         |          | ocessing |
|             |          |           |         |          | for food |
|             |          |           |         |          | and feed |
|             |          |           |         |          | use      |
+-------------+----------+-----------+---------+----------+----------+
| Corn/ Zea   | H        | Pioneer   | NK-603  | Glu      | Field    |
| mays        | erbicide |           |         | fosinate | trials   |
|             | T        |           |         | tolerant |          |
|             | olerance |           |         |          |          |
+-------------+----------+-----------+---------+----------+----------+

## Notification Dossier

The notification must include:

\-- a technical dossier providing specified information for carrying out
the environmental risk assessment, especially: (i) general information
on the notifier, including information on personnel and training; (ii)
information regarding the genetically modified organism/organisms; (iii)
information regarding the conditions of the release and the
characteristics of the potential recipient environment; (iv) information
regarding the impact of the genetically modified organism/organisms on
the environment; (v) a monitoring plan, to identify the effects of the
genetically modified organism/organisms on human health and environment;
(vi) information on control and corrective methods, waste treatment and
emergency response plans; (vii) a summary of the dossier.

\-- the environmental risk assessment study together with any
bibliographic references and indications of the methods used;

\-- information regarding the results of the release of the same
genetically modified organisms or of the same combinations of
genetically modified organisms on the territory of Romania or elsewhere.

The notifier may refer to the data or the results from the notifications
previously submitted by other notifiers, provided that the information,
data and results are not confidential or the notifier has their consent.
Simplified procedures may apply for GMOs already notified and/or
approved in EU members and in OECD countries. In this situation, the
notifier will present: (i) either a copy of the notification summary
submitted by the national competent authorities in the member states to
EU and OECD; (ii) or a copy of the EU and OECD documents which approve
the release of the genetically modified organism on the territory of the
member states.

## Co-existence

## 

Currently, Romanian authorities have not developed any co-existence
rules, as the only transgenic crop approved for commercial cultivation
is soybean. Nonetheless, this is expected to change very soon and the
EU-line to be adopted, especially given that the Ministry of Agriculture
recently stated its priority to encourage ecological (organic) agronomic
practices. Organic products are not restricted by CAP quotas and, being
labor-intensive, are assessed to be able to absorb in the middle-term,
the social shocks of an agricultural sector struggling to adapt itself
to meet the new competitiveness requirements of the enlarged common
market.

## Rules Governing the Movement and International Trade of Transgenic Products

Romania is signatory to the Cartagena Protocol on Biosafety, according
to the Ratification Law 59/March 2003. Although the Protocol requires an
exporting country to seek consent from an importing country only prior
to the first shipment (first trans-boundary movement) of a living
modified organism (LMO) intended for intentional introduction into the
environment, the Romanian national legislation exceeds this framework
and requires companies to adhere to complete biotech product importation
procedures (as described below) for every shipment of biotech seeds
entering Romania for planting. This represents a real challenge facing
local subsidiaries of U.S. biotech companies, forced every year to
notify separately **each import of a commercially approved
transformation event**.

Romanian national legislation (Law 214/2002) provides that the following
information must be presented to the competent national authority (i.e.,
Ministry of Environment) in notifications concerning documented
authorization every time import/export activities of genetically
modified organisms are to be performed:

a)  Name, address and contact info of the exporter.

b)  Name, address and contact info of the importer.

c)  Name and identity of the living modified organism, as well as the
    domestic classification, if any, of the biosafety level of the
    living modified organism in the State of export.

d)  Intended date or dates of the trans-boundary movement, if known.

e)  Taxonomic status, common name, point of collection or acquisition,
    and characteristics of recipient organism or parental organisms
    related to biosafety.

f)  Centers of origin and centers of genetic diversity, if known, of the
    recipient organism and/or the parental organisms and a description
    of the habitats where the organisms may persist or proliferate.

g)  Taxonomic status, common name, point of collection or acquisition,
    and characteristics of the donor organism or organisms related to
    biosafety.

h)  Description of the nucleic acid or the modification introduced, the
    technique used, and the resulting characteristics of the living
    modified organism.

i)  Intended use of the living modified organism or products thereof,
    namely, processed materials that are of living modified organism
    origin, containing detectable novel combinations of replicable
    genetic material obtained through the use of modern biotechnology.

j)  Quantity or volume of the living modified organism to be
    transferred.

k)  A previous and existing risk assessment report.

l)  Suggested methods for the safe handling, storage, transport and use,
    including packaging, labeling, documentation, disposal and
    contingency procedures, where appropriate.

m)  Regulatory status of the living modified organism within the State
    of export and, if the living modified organism is banned in the
    State of export, the reason or reasons for the ban.

n)  Result and purpose of any notification by the exporter to other
    States regarding the living modified organism to be transferred.

o)  A declaration that the above-mentioned information is factually
    correct.

## Trade Barriers

Commercialization of herbicide resistant soybean in Romania is currently
hindered by technical barriers related to the manner in which the
Romanian authorities implement the Cartagena Protocol (see section on
Rules Governing the Movement and International Trade of Transgenic
Products) as well as related to an excessive interpretation of the
traceability concept. Regarding the latter, the NA conditions the
release of the annual approval for commercial cultivation to the
notifying seed companies by receiving the list of locations where
transgenic soy seeds will be planted. As the whole paperwork is done
prior to the actual importation, the seed companies cannot possibly
anticipate, in a free market and in an agricultural business model,
affected by numerous variables, where precisely and to whom they will
sell the products. Once the list of locations at the county level is
communicated to NA, as per NA's requirement, it cannot be changed
without going again through the entire approval process, with all
regulatory Ministries and Agencies.

Another condition laid down to the two seed companies in the Approval
issued in 2005, is to provide contact information for the buyers of the
harvest. This is another example of an excessive interpretation of the
traceability requirements, as the seed company does not have control
over the harvested product. The Companies only have the obligation to
provide their customers all relevant information about the legal
requirements related to biotech crop regime prior to concluding the
Sales-Purchase contract.

## Intellectual Property Rights

Although this aspect is regulated in Romania via a number of laws and
Government Decisions (Law 285/2004 on copyright and connected rights, GD
1424/2003 for approving the National Strategy in Intellectual Property
Rights, GD on the Organization of the State Office for Inventions and
Trademarks, etc.), the company that was issued the initial approval for
importation for commercial planting of the GM soybeans (Glycine max.
line GTS 40-3-2) tolerant to glufosinate herbicide in 2002 does not
collect royalties, because it did not register the patent in the first
year when the technology was introduced into Romania.

# IV. MARKETING ISSUES

Despite repeated attempts by a number of anti-biotech organizations to
influence public opinion through sensational newspaper headlines,
consumers' hostility towards bioengineered food is superficial and there
are good chances to increase the acceptance of GMO crops by providing
scientifically sound information.

# V. CAPACITY BUILDING AND OUTREACH

A well-defined biotechnology program funded by USAID with technical
assistance from FAS is currently on-going in Romania with the objective
of helping Romania explore ways of coming into the EU with a viable
biotech industry and support farmers who are successfully producing and
marketing their products in an EU-compliant system. This effort targets
primarily high-level political biotech policymakers and has resulted in
various activities in CY2004 and 2005 (policy roundtable discussions,
fieldtrips to farms using biotechnology, a study tour in Spain[^1]).
Additionally, an educational campaign was conducted in May-June of this
year, with the aim of explaining to farmers, via town hall meetings,
about the national and EU regulatory system as well as their obligations
pertaining from this system.

In order to support Romania's capacity to properly implement biotech
regulation and innovation, funds for the purchase of biotech lab
equipment at Banat Agricultural University were allocated from the joint
USDA/USAID Agricultural Development and Policy Support Project to
support Romania's ability to evaluate biotech products. (Note: Banat\'s
Lab is currently seeking accreditation as a reference laboratory).

During FY2006, six Romanian young scientists have been selected for
training in U.S. universities on biotech-related issues, under the
Borlaug Program funding.

With the goal to facilitate a balanced, open dialogue and provide
broader availability of scientific information about agricultural
biotechnology to both the media and everyday consumers, Romanian press
representatives have been selected to participate in the Media Study
Tour organized by the International Grains Council in 2004 and 2005, an
event about which our office received excellent references.

Complementary programs are being sponsored by the State Department under
various initiatives (International Visitor Program -- IVP, Voluntary
Visitor Program -- VolVis) and a recently approved biotech outreach for
a broad public educational campaign to reach the organizations of
farmers, compound feeders, poultry and swine producers and oilseed
crushers. The proposed program builds on existing contacts, local
expertise and USAID and FAS matching funds.

Between March 6-12, 2005, a Romanian official took part, together with
counterparts from new EU member states (Cyprus, Estonia, the Czech Rep.,
Latvia, Poland, Slovakia, Slovenia and Hungary) in a biotech study tour
in US, sponsored by the US Department of State under a Voluntary Visitor
(VolVis) Program. The program aimed at introducing officials from these
countries to the US regulatory system of modern agricultural
biotechnology, specifically to aspects related to testing, registration
and utilization of genetically modified crops. This was achieved through
an intense five-day agenda of various meetings of the group with the
federal agencies with competences in biotech, as well as a field trip.

[^1]: A team of Romanian officials from various GOR ministries and
    agencies with roles in regulating biotech products, led by USDA/FAS
    Bucharest staff, traveled at the end of September in central and
    northeastern Spain to first-hand witness how biotech crops are
    regulated and monitored, especially from the perspective of the new
    EU legislative framework for labeling, traceability and placing on
    the market of GM food and feed (Regs 1829/03 and 1830/03), which
    became fully applicable on April 18, 2004. The agencies/bodies
    represented to this event were the Ministry of Waters and
    Environment (the biotech competent authority in Romania), the
    Ministry of Agriculture, Forests and Rural Development, the National
    Authority for Consumer Protection, the Biosafety Commission. FAS
    Madrid facilitated what was unanimously found to be a very
    productive program for the study tour. By meeting with their Spanish
    counterparts, the Romanian regulators were extensively explained
    about the evaluation of GMOs in Spain and the biotech approval
    process in EU, recently resumed.