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6-Regulation: Revising seed purity laws for successful identity preserved production

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SOURCE: Agricultural Management Committee Newsletter Vol 10(2)
        American Bar Association, USA, by A. Bryan Endres
DATE:   Feb 2006

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As an increasing number of farmers plant varieties derived from modern
biotechnology, the potential for the adventitious mixture of genetically
modified (GM) DNA with products produced via organic and conventional
(non-GM) methods also rises.

Accordingly, the ability of farmers to choose between conventional,
organic or GM crop production and achieve required purity levels--
commonly referred to as coexistence--is increasingly difficult.

Despite notable and, ultimately, expensive failures such as the
admixture of StarLink varieties approved only for use as animal feed
with corn destined for human consumption or ProdiGene Inc.'s commingling
of nonregulated soybeans with corn genetically engineered to produce
pharmaceuticals, farmers, grain handlers and processors have made some
progress in implementing on farm and post-harvest segregation and
identity preservation systems to minimize the adventitious presence of
GM DNA. Little attention, however, has been directed to "the irreducible
core of crop production on the farm and the most fundamental
agricultural input"--the seed. JACK R. KLOPPENBURG, JR., FIRST THE SEED:

The undisputed starting point for a successful non-GM identity
preservation system is ensuring seed purity.

Unfortunately, existing seed laws at both the federal and state level do
not address directly the adventitious presence of genetically modified
organisms (GMOs) in seed. Recent preliminary studies by the Union of
Concerned Scientists, as well as anecdotal evidence from a preliminary
study at the University of Illinois, strongly suggest that GMOs are
present at low levels in seed marketed to farmers as conventional and,
perhaps more importantly, in foundation seed stocks where each
potentially contaminated seed produces multiple offspring. A study by
the European Commission's Scientific Committee on Plants also concluded
that as the area under GM production increases, the adventitious
presence of GM seeds grows along with a corresponding increase in the
difficulty of obtaining seed with purity levels capable of meeting the
European Union's traceability and labeling thresholds.

Federal and state seed purity laws could, if revised, provide a critical
first step in the achievement of coexistence in the United States and
preserve commodity agricultural exports to the European Union and other
major export destinations. Although the adventitious presence of GM DNA
in seed marketed as conventional or organic probably cannot be
eliminated entirely, it could be minimized and tolerances that are
practically and economically feasible should be established within the
framework of existing seed laws.

In reaching this conclusion, the article briefly compares both
coexistence and seed purity rules in the United States with developing
rules in the European Union.

The European Union's approach, which directly addresses the question of
adventitious presence of GM DNA in conventional seed stocks, may provide
a helpful benchmark for revising domestic seed laws and an important
step toward coexistence.

The Path to Coexistence: Formal or Informal

Farmers have long practiced variations of modern segregation and
identity preservation, including adoption of successful coexistence
strategies in a variety of production situations. For the most part,
informal production methods have evolved in the absence of a formal
legal regime. Seed and specialty crop producers have historically borne
all of the costs necessary to achieve desired purity standards, such as
set backs, crop rotation and segregation requirements.

In addition to the direct costs of establishing and maintaining
coexistence, non-GM farmers generally bear all of the financial risk if
their systems fail. No reported case has assessed liability for the farm-
tofarm admixture of genetically modified DNA via pollen drift. Moreover,
seed companies usually attempt to pass all risk of adventitious presence
to the purchaser by disclaiming implied warranties of fitness or
merchantability. The International Seed Federation's model disclaimer is

Seeds supplied to you are from a variety bred from parent components
that have not been genetically modified. . . .. . (Company name) has
undertaken due diligence to avoid adventitious presence of GM material
in this seed lot. However, (company name) gives no guarantee that the
seed is GM free and can accept no liability arising from the
adventitious presence of GM material.

International Seed Federation, Model Conditions of Sale Disclaimer,
available at Position_papers/cond_sale.htm. Although
recent legal innovations such as the establishment of grower districts
and/or GM-free zones may minimize some of the on-farm costs of
preserving a non-GM harvest, coexistence remains a significant challenge
for many farmers.

In contrast, the European Union has taken initial steps to formalize a
framework of responsibilities for obtaining coexistence and accompanying
best management practices. See Commission Recommendation 2003/556. Under
the European Commission's guidelines, Member States must strive to
ensure that farmers have the ability to "make a practical choice between
conventional, organic and GM crop production, in compliance with the
legal obligations for labeling and/or purity standards." Id.

Key implementation principles include the requirement that a farmer
introducing a new production type in a region (presumably GM crop
production) must bear responsibility for implementing farm management
measures necessary to limit admixture. In addition, the Commission
directed Member States to establish mechanisms favoring coordination and
voluntary arrangements among neighbors.

These proposed rules present a stark contrast to the adoption of GM
production methods in the United States, where the absence of regulatory
rules subsidizes the adoption of GM production. Domestic producers are
free to disregard production practices on neighboring farms and pass all
segregation costs onto the non-GM farmer. European producers, on the
other hand, experience a high cost in switching to GM production
methods. In addition to on-farm management costs, European GM producers
may face substantial liability risks in the event of economic damage
resulting from admixture as Member States refine their civil liability
laws. As a result, the adoption of GM technology by farmers in the
European Union may be slowed even further.

Examining Seed Laws in the European Union and United States

As guardian of a "single market," the European Union approves the sale
of seeds at the Community level.

Directive 2002/53/EC codified earlier legislation that established a
Common Catalog of each variety of agricultural plant species accepted
for certification and marketing in the Member States. Once listed in the
Common Catalog, seed varieties are freely marketable.

Separate Community-level directives establish specific certification
standards for marketing each type of seed and plant propagating
material. Genetically modified varieties may be included in the Common
Catalog only after approval in accordance with Regulation 1829/ 2003,
the regulation authorizing the placing on the market of products
consisting of, containing, or produced from GMOs. Moreover, the catalog
listing and all labels must clearly indicate that the variety is
genetically modified. Although current seed certification and marketing
directives do not set a tolerance level for the adventitious presence of
GM seeds, the European Commission is considering legislation that would
establish labeling thresholds at a level low enough to ensure the
harvested crop could satisfy the 0.9 percent threshold for traceability
and labeling.

The Scientific Committee on Plants of the European Commission
acknowledged that a zero level of adventitious GM seed is unobtainable
in practice and instead recommended thresholds of 0.3 percent for cross-
pollinating crops and 0.5 percent for selfpollinating vegetatively
propagated varieties. A 2003 Commission Staff Working Paper recommended
thresholds of 0.3 percent for rape (canola), 0.5 percent for maize and
0.7 percent for soybeans.

The required thresholds were calculated to produce an end-product with a
GM presence of approximately 0.8 percent, leaving a margin vis a vis the
0.9 percent labeling threshold for final products. Of course, any Europe-
wide labeling requirement would not a priori guarantee acceptance of the
harvested crop as non- GM. Farmers would have to practice adequate farm
level and post-harvest segregation measures to preserve genetic purity.

Unlike the developing regulatory system in Europe, the Federal Seed Act,
7 U.S.C. 1551-1611, and most state seed laws do not require disclosure
of low levels of adventitious presence of GM seeds. The Federal Seed Act
does require that labels on all seed sold in the United States include,
inter alia, the name of the kind or variety of seed present in excess of
five percent of the whole, the percentage of each kind or variety and
for each variety included on the label, the percentage of germination,
the percentage of hard seed and the date the test was completed to
determine the respective percentages. GM seed is considered the
"variety" of its broader "kind" of seed. With respect to adventitious
presence in seeds marketed as conventional, GM seeds would fall into the
"other crop" or "other variety" category. Therefore, if the GM variety
is present in less than five percent of the whole, designation on the
label is not required. On the other hand, if GM seed constitutes more
than five percent of the whole, it must be indicated on the label.

Enforcement of the Federal Seed Act's requirements is through
cooperative agreements with state governments. States are responsible
for collecting and testing seed samples for compliance with the Federal
Seed Act, as well as applicable state laws. Subject to broad federal
guidelines, state seed agencies have discretion to test however they see
fit. For example, states may choose to test a certain amount of each
type of seed, or they may choose to test particular companies that have
mislabeled seed in the past.

Enforcement is tempered, however, by a statutorybased "safe-harbor"
provision. No violation of the Federal Seed Act's labeling requirements
occurs if kinds or varieties of seeds present above the five percent
threshold are not included on the label "because of their
indistinguishability in appearance from the seeds intended to be
transported or delivered for transportation in interstate commerce." At
this time, the scope of the "indistinguishable in appearance" exception
is unclear as it relates to the adventitious presence of GM seed.
Detecting the presence of GM DNA from current commercially marketed
varieties requires sophisticated laboratory analysis, such as polymerase
chain reaction (PCR) testing. PCR testing, however, requires "primers"
that locate and replicate the targeted DNA within the sample. In other
words, PCR testing will find and measure known contaminants, but will
not identify GM DNA for which a primer is unavailable. Accordingly, GM
material that has not received regulatory approval is unlikely to be
detected. A recent example of this defect is the latent presence for
several years of Syngenta's unapproved Bt10 corn variety in domestic
seed supplies. The outward appearances of most GM seeds are
indistinguishable from their conventional counterparts. The question,
therefore, is whether the agency would require PCR or other
sophisticated DNA testing of seeds to distinguish their "internal
appearance" and eliminate the safe-harbor for companies marketing seeds
with an adventitious presence of GM DNA above the legal threshold.

Most state seed laws closely track the federal version and,
unfortunately, do not offer conventional and organic farmers any
additional protection from the adventitious presence of GM DNA in seeds.
Often, the only significant difference between federal and state law is
the listing of additional noxious weed seeds.

A few states, however, have modified their respective seed laws to
account for the advent of GMOs.

Vermont's seed law, VT. STAT. ANN. TIT. 6,  611(c), now mandates
"identification of seeds that have been genetically engineered." It is
unclear as of this writing whether the state will set a tolerance level
for the adventitious presence of GM seed, or simply require labeling for
adventitious presence above the federal five percent threshold.

Seed purity enforcement agencies in two other states, Kentucky and
Mississippi, have also taken first steps in dealing with GM seed. In
Kentucky, the Division of Regulatory Services is testing, as time and
money permits, old seed samples to determine the level of adventitious
presence of GM seed. In 2000, Mississippi amended its Pure Seed Law to include

"transgenic seeds" in its definition of "agricultural seeds." Transgenic
seeds are also mentioned specifically in the seed law as something that
the Commissioner of Agriculture and Commerce should sample, test and analyze.

Despite advances in a few states, the United States as a whole lacks any
coordinated effort to determine and label the extent of adventitious
presence of GM varieties in the seed supply.

Revising the Seed Laws to Foster Coexistence

As recent negotiations regarding the Biosafety Protocol reveal, a
consensus on labeling and tolerance levels (0.9 percent in the European
Union versus 5 percent in the United States) is unlikely. Producers
attempting to market products to many trading partners will have to
navigate a patchwork of regulations and comply with the higher end-
product standards while using inputs (i.e., seeds) with less stringent
tolerance levels.

In conjunction with voluntary labeling by seed sellers, a more complete
study of the extent of adventitious presence should be undertaken to
assess the nature and scope of the problem. Assuming a full study
confirms preliminary findings that the domestic seed supply is
contaminated with low levels of GM DNA, federal and state lawmakers and
seed regulatory agencies should take affirmative steps to restore the
integrity of the seed production system and revise existing labeling
laws to provide conventional and organic farmers accurate information.

Although adventitious presence thresholds below one percent may be
difficult to achieve without an increase in costs, it is essential to
have clear labeling standards to provide farmers an opportunity to
produce a harvested crop that will meet the import standards of major
trading partners and the purity demanded by consumers of identity-
preserved and organic products.

Seed purity standards should be set according to sound science and at a
level that considers the degree of potential post-planting admixture.
Proposed standards developed by the European Union's Scientific
Committee on Plants of 0.3 percent for corn and 0.5 percent for soybeans
provides a starting point for discussion and further evaluation.

In order to meet the requirements of any new labeling rules, however,
seed certification and testing agencies must have the necessary
technology (e.g., primers for PCR analysis) to test for the adventitious
presence of GM DNA. An international database of GM DNA and testing
procedures (that includes testing material for genetic engineering
events that have not yet received final regulatory approval) should be
compiled, and maintained in a manner that preserves the intellectual
property of the seed developers. A functioning database may have
detected earlier the presence of Syngenta's Bt10 variety that is now
hampering export shipments and prevented at least some spread of the
unauthorized variety.

Finally, the agricultural production system has faced similar challenges
in the past and crafted workable solutions. Coexistence is possible to
obtain and will require similar creativity on the part of the world's
policymakers and the agri-business community. A new look at seeds laws
is a logical, and necessary, first step.

A. Bryan Endres is an assistant professor of Agricultural Law at the
University of Illinois. An extended version of this article may be found
in Volume 1 of the JOURNAL OF FOOD LAW & POLICY, pp. 131-163 (2005),
portions of which are reprinted here with permission. This research is
supported by the Cooperative State Research, Education & Extension
Service, United States Dept. of Agriculture, Project No. ILLU-05-309.

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