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May 2011Vol. 15, No. 2

MESSAGE FROM THE CHAIR

James H. Andreasen

Another successful meeting in Salt Lake City touchedlightly on food and agriculture issues, with sessionsrelating to Gulf of Mexico seafood safety and climatechange. In the near future, we will see agriculture—including aquaculture—playing a key role in feeding theworld while also controlling unwanted emissions andsequestering carbon.

As planting season approaches, waves of uncertaintyover which biotech crop has approval for planting aresweeping the nation, and many growers in Californiaare wondering whether they will have enough water tomaintain their fields or orchards. We open with JillianHishaw’s update of agricultural environment case law(assisted by editor Tom Redick), including a SixthCircuit case allowing rBST milk labeling despite anOhio ban on such commercial speech, a recent CAFOdecision out of the Fifth Circuit and several caseschallenging biotech crops. Tom Redick offers anupdate on the world food crisis, followed by BettyKiplagat’s summary of biosafety liability issues. Turningto California’s water woes, Mia Brown provides afocused look at one of the emerging challenges toagriculture—sustainable uses of water for endangeredfish species vs. agricultural uses.

In a point-counterpoint on biotech and organic crops,Vice Chair Martha Noble addresses organicagriculture’s ability to provide food for the world, whileVice Chair Brandon Neuschafer outlines the

contributions that biotechnology could make. Lastly,Stan Benda offers a philosophical perspective on thebiotech crop positions of the European Union and theUnited States.

This case law update and the articles that followillustrate the challenges of feeding the world—canfarmland be preserved when property rights areinvolved? What is the role of federal power ininterstate commerce, and does it trump state lawdecisions on health and environmental protection?

We will be gathering in Indianapolis for the 19thSection Fall Meeting (October 12–15, 2011). It is nottoo soon to begin planning for this meeting, which issure to have useful information for the agriculturalenvironmental law attorney. We had student volunteersin Salt Lake, and hope to have more in Indianapolisthis fall. If you have ideas for programs or would liketo write for our newsletter, please send me or TomRedick an e-mail and we will find a way for you tocontribute. Young lawyers, students, and consultantsare encouraged to jump in—experience is not requiredto make a difference in SEER.

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Agricultural ManagementCommittee NewsletterVol.15, No. 2, May 2011Thomas P. Redick, Editor

In this issue:

Message from the ChairJames H. Andreasen ..................................... 1

Case Law Update: Biotech Crops, rBST, FarmlandPreservation, and the CAFO RuleJillian Hishaw and Thomas P. Redick ............ 3

State of the World’s Food SupplyThomas P. Redick ......................................... 6

Liability and Redress: The Supplementary Protocolto the Cartagena Protocol on BiosafetyBetty Kiplagat ................................................ 8

Little Fish, Big Problem: Endangered Fish ImpactsLarge-Scale Water DeliveriesMia S. Brown.................................................11

The Role of Biotechnology in SustainableAgricultureBrandon W. Neuschafer ............................... 13

How to Feed the World In 2050? The Need forOrganic and Sustainable Farming SystemsMartha Noble ............................................... 17

Regulatory Differences in EU/U.S. Approaches toGenetically Modified CropsStan Benda, Ph.D. ....................................... 24

Copyright © 2011. American Bar Association. Allrights reserved. No part of this publication may bereproduced, stored in a retrieval system, ortransmitted in any form or by any means,electronic, mechanical, photocopying, recording,or otherwise, without the prior written permission ofthe publisher. Send requests to Manager,Copyrights and Licensing, at the ABA, e-mail:copyright@americanbar.org.

Any opinions expressed are those of thecontributors and shall not be construed torepresent the policies of the American BarAssociation or the Section of Environment,Energy, and Resources.

Upcoming Section Programs—

For full details, please visit the “Events &CLE” link on our Section Web site:http://www.americanbar.org/groups/environment_energy_resources.html

May 17, 2011EPA Regulation of Electric Generation: TrainWreck or Clearing the Tracks for the NewEnergy Economy?Primary Sponsor: Edison Electric InstituteWashington, DC

May 19, 2011Nano Governance: The Current State ofFederal, State, and International RegulationQuick Teleconference

May 26-27, 201115th Institute for Natural Resources LawTeachersPrimary Sponsor: Rocky Mountain MineralLaw FoundationStevenson, WA

August 4-9, 2011ABA Annual MeetingToronto

October 12-15, 201119th Section Fall MeetingIndianapolis

February 22-24, 201230th Annual Water Law ConferenceSan Diego

March 22-24, 201241st Annual Conference on EnvironmentalLawSalt Lake City

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CASE LAW UPDATE: BIOTECH CROPS,RBST, FARMLAND PRESERVATION, AND

THE CAFO RULE

Jillian Hishaw and Thomas P. Redick

International Dairy Food Association v.Robert J. Boggs, Ohio Department ofAgriculture, Nos. 09-3515/3526 (September30, 2010)

On September 30, 2010, the Sixth Circuit Court ofAppeals reversed the lower court’s decision supportingOhio’s prophylactic ban on “non-rBST” claims on milkproducts that distinguish rBST-treated and non-rBSTtreated dairy milk (rBST is a genetically modifiedhormone that increases milk production in dairy cowsby 10 percent)[. FDA approved this veterinary drug in1993 and issued voluntary labeling guidance in 1994,discouraging display of composition of product (e.g.,“rBST free” is not allowed, because the milk containsnatural hormone traces), while encouraging truthful“production claims” that refer to the process usedleaving no detectible residues in products (e.g., “fromcows not treated with rBST”). After years of activistcampaigning against it, Starbucks and many dairyprocessors of the International Dairy Food Association(IDFA) joined the Organic Trade Association (OTA) inno longer selling rBST milk.

In May 2008, after IDFA and OTA members(processors) placed non-rBST labels on milkproducts, Ohio restricted the types of labeling claimsdairy processors placed on milk products. Under thislaw, any claims stating “No Hormones,” “HormoneFree,” “rBST Free,” or “No Artificial Hormones”would be “false and misleading advertising.” IDFA andOTA challenged the regulation as an infringement ontheir First Amendment rights in violation of the dormantCommerce Clause (void-for-vagueness).

The lower court granted summary judgment for Ohioon all but one of these claims, applying the four-parttest stated in Central Hudson Gas & Electric Corp.v. Public Service Commission, 447 U.S. 557(1980). Under the first prong of this four-part test, acompositional claim would appear to be “inherently

misleading” given FDA’s policy discouraging suchclaims. Processors appealed the court’s rejection oftheir First Amendment and Commerce Clause claims.The court of appeals reversed and remanded, findingthe evidence actually supported a compositionaldifference between milk from untreated cows andconventional milk, emphasizing rBST risks including“several types of cancer” and lower quality milk (higherfat, turns sour faster, lower protein, etc.). In particular,the court relied on a study conducted by the Center forFood Safety. Second, the court found Ohio failed toprovide sufficient facts to show that claims of“antibiotic free” and “pesticide free” were inherentlymisleading.

After making this initial finding that the non-rBSTclaims were not inherently misleading, the court ofappeals also found that the rule’s prophylactic ban ofcomposition claims such as “rBST free” was moreextensive than necessary to serve the state’s interest.The disclosure of additional information in a disclaimer(e.g., “The FDA has determined that no significantdifference has been shown between milk derived fromrBST-supplemented and non-rBST-supplementedcows”) would be less burdensome than a totalprohibition on commercial speech under the FirstAmendment.

In related Commerce Clause analysis, the court ofappeals reversed to allow use of that disclaimer (whichprocessors claimed would unduly burden interstatecommerce), holding the disclosure requirement validunder the less burdensome reasonableness standard ofZauderer v. Office of Disciplinary Counsel of theSupreme Court of Ohio, 471 U.S. 626 (1985)(stating a more lenient standard than Central Hudsonscrutiny for disclosure requirements vs. prohibitions onspeech) rather than intermediate scrutiny underCentral Hudson. Lastly, the court of appeals held thatOhio’s rule does not have an extraterritorial effect inprojecting the effects of its labeling ban on the dairyprocessors’ commerce with other states. The decisionis posted online at www.ca6.uscourts.gov/opinions.pdf/10a0322p-06.pdf.

Building Industry Association v. County ofStanislaus, Court of Appeals of California,

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5th District, No. F058826 (November 29,2010)

In an effort to update the Stanislaus County farmmitigation plan, in December 2007, the StanislausCounty Board required a 1:1 ratio; for every one acreof farmland converted to non-agricultural use, one acremust be protected in a conservation easement. For 20-acre or greater parcels, developers are required tomitigate upon permit approval. In opposition theBuilding Industry Association of Central California(BIA), challenged the legal validity of the mitigationrequirement. The trial court sided with BIA citing theboard’s lack of legal authority beyond the county’spolice powers. Additionally, the court held the boardfailed to show a reasonable relationship betweenindustry impact and public protection. Lastly, themitigation plan violates state law that prohibits localgovernment from placing a condition approval on theissuance of a conservation easement.

The California Supreme Court reversed the lowercourt’s decision. First the supreme court stated thelower court improperly gave the county the burden ofproving the relationship of industry impact versusprotection. The court found the protective purposevalid since agriculture is the top grossing revenue in thecounty. Given the county’s pristine soil, water andfavorable climate, the loss of farmland to residentialdevelopment would be irreplaceable. The court foundthat BIA failed to prove that the mitigation requirementhad no relationship to land protection. Second, thecourt ruled the county had police power to mandateland use regulations under the constitution. Third, thecounty’s language met the statutory description and useof a conservation easement that is fitting under statelaw. For land transactions of 20 acres or less,[payment of an in-lieu mitigation fee is acceptable ifdiligent efforts to obtain a conservation easementfailed. However, for 20 acres or more,mitigationregarding a conservation easement is required butsubject to alternative means upon board approval. BIAargued that requiring a developer to utilize aconservation easement during the mitigation processcreates an involuntary conveyance on the developer’spersonal property rights. The court stated that the

actual granting of a conservation easement is voluntaryand open to third-party transaction.

Biotech Sugar Beets—Center for FoodSafety v. Vilsack, 3:08-cv-00484-JSW(August 13, 2010), and Grant v. Vilsack,1:11-cv-00308-JDB ((February 7, 2011)

In August 2010, Jeffrey White of the U.S. DistrictCourt in San Francisco ruled the U.S. Department ofAgriculture (USDA) was in violation of the NationalEnvironmental Protection Act (NEPA) in allowing theplanting of genetically modified (GM) beets withoutperforming an environmental impact statement (EIS).Despite the ruling prohibiting the commercialization ofGM sugar beets, on February 4, 2011, the USDAbegan approving permits for the spring planting of GMsugar beets due to industry pressures subject toconditions that appeared to respond to the “partialderegulation” suggested by the U.S. Supreme Court inits RR Alfalfa decision (Geertson Seed Farms v.Monsanto, 130 S. Ct. 2743 (2010)). On February 7,2011, plaintiffs in Grant v. Vilsack filed a complaintseeking to affirm the USDA partial deregulation, whilechallenging a few elements (e.g., planting distances,etc.) that producers found excessive.

On February 7, 2011, the Center for Food Safety fileda new complaint in the U.S. District Court of NorthernCalifornia, challenging USDA’s injunction violation andNEPA. On February 18, 2011, the U.S. district courtdenied the motion to amend to add this challenge toUSDA’s February 4 decision. Center for Food Safetyv. Vilsack, 3:10-cv-04038-JSW (Feb. 18, 2011).This case may be appealed, so stay tuned to thisnewsletter for further information.

Alfalfa Litigation: Center for Food Safety v.Vilsack, No. Cv11-1310

For a second time, the Center for Food Safety (CFS),Earthjustice, and others sued the U.S. Department ofAgriculture, to vacate the post-EIS unrestrictedapproval of Roundup Ready® alfalfa. In the complaintfiled in Center for Food Safety v. Vilsack, No.Cv11-1310, available at http://www.centerforfoodsafety.org/wp-content/uploads/2011/03/

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1-Complaint.pdf, CFS alleged that USDA’s “reckless”nationwide approval in February 2011 ignoredoverwhelming evidence that genetically engineered(GE) alfalfa threatens the rights of farmers andconsumers, as well as causing significant harm to theenvironment and bowing to the biotech industry. CFSalleged that USDA data showed 93 percent of U.S.alfalfa uses no herbicides, turning the planting of RRalfalfa into a significant negative environmental impact.CFS also suggests that “contamination” of organic andnon-GM alfalfa will be unavoidable

USDA’s decision to grant nationwide approval hingedupon its “limited authority” which restricts its scope to“plant pest” risks. Other pending litigation by CFSagainst GE eucalyptus trees challenges USDA to usethe 2008 Farm Bill (which still has not been fullyimplemented by USDA) to expand its regulatoryoversight to include “other effects” of “noxious weeds”to put herbicide-resistant crops into tightercontainment.

National Pork Producers Council v. EPA, 08-61093 (March 15, 2011)

In a recent decision of the Fifth Circuit Court ofAppeals, EPA’s controversial CAFO rule (published2008) regulating concentrated animal feedingoperations (CAFO) to obtain wastewater dischargepermits under the Clean Water Act (CWA) was struckdown. This is the second time EPA’s decisions havebeen successfully challenged. In 2005, the U.S. Courtof Appeals for the Second Circuit in New York Cityvacated key aspects of the first regulation (published2003) ruling that the CWA requires National PollutantDischarge Elimination System (NPDES) permits onlyfor actual—not “potential”—discharges of CAFOwaste. EPA tried another approach in 2008, and thatwas rejected as well. See Nat’l Assoc. State Depts.Agric., 5th Circuit Rebuffs EPA CAFO Rule (Mar. 15,2011), www.nasda.org/cms/7197/9060/30366/30380.aspx.

The Fifth Circuit joined the Second Circuit in rulingagainst the EPA regulation that required a permit evenwhen the facility is not actually discharging wastewater.National Pork Producers Council v. EPA, 08-

61093 (Mar. 15, 2011), available at http://civileats.com/wp-content/uploads/2011/03/NPPC-etal-vs.-EPA.08-61093-CV0.wpd.pdf. The FifthCircuit held that EPA’s effort to extend the CWAbeyond entities that actually discharge—and to seekpenalties merely for failing to apply for a permit—exceeded EPA’s CWA authority. This is deemed amajor victory for the livestock industry. See, e.g.,National Pork Producers Council Press Release,NPPC Scores CAFO Suit Victory over EPA (Mar.15, 2011), http://www.nppc.org/ews/DocumentSingle.aspx?DocumentID=26327.

Jillian Hishaw is an adjudicator for the USDACivil Rights Division in Washington, D.C. She canbe reached at jhishaw77@yahoo.com. Thomas P.Redick practices law as Global EnvironmentalEthics Counsel in St. Louis, Missouri, and isnewsletter coordinator for SEER and editor of theAgricultural Management Committee Newsletter(e-mail: thomasredick@netscape.net).

One Million Trees Project—Right Tree for the Right Place

at the Right Time

Join Section efforts to plant one million trees by 2014.This project calls on ABA members to contribute tothe goal of planting one million trees across theUnited States in the next five years. In addition toplanting trees, the Section also intends, throughpublic outreach and partnering efforts, to raise thenation’s awareness of the multiple benefits of trees.To participate in the One Million Trees Project,please click on the “Projects & Awards” link on ourSection Web site:

http://www.americanbar.org/groups/environment_energy_resources/

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STATE OF THE WORLD’S FOOD SUPPLY

Thomas P. Redick

In a recent TV interview, French Farm Minister BrunoLe Maire accused high commodity prices of having“disastrous effects on farmers, consumers, anddeveloping countries,” suggesting that steps must betaken to curb volatility. If prices continue to rise in2011, the world may see a repeat of the 2008 foodriots. See Reuters Insider TV, http://bit.ly/eULT8q.Reports range from growers celebrating the goodfortune of high prices to animal feeding operationscomplaining of the same price hike. Amid generalconcern over the impact on the economy there areinflammatory accusations that policy decisions,including corn-based ethanol, are driving high foodprices (see, e.g., AP Newswire, Wholesale PricesSpike on Steep Rise in Food, Oil, ST. PETERSBURG

TIMES, Mar. 17, 2011, http://www.tampabay.com/news/business/personalfinance/wholesale-prices-spike-on-steep-rise-in-food-oil/1157789 (AP Steep Rise)).Bloggers suggested that U.S. policies were to blame inpart for historically high milk prices and $7 corn. See,e.g., Jeffrey Folks, Obama’s High Food Price PolicyStealing Milk from Babies (Mar. 29, 2011), http://www.americanthinker.com/2011/03/obamas_high_food_price_policy_1.html.

Food prices soared nearly 4 percent in February, aprice hike not seen since November 1974. WithSouthern agriculture suffering winter freezes, freshvegetable prices soared, representing 70 percent of theincrease. The price of a basic salad trio of tomatoes,green peppers, and lettuce more than doubled, whilemeat and dairy costs rose as prices for animal feed(corn and soybeans) reached record highs. As thisarticle was going to press, commodities from gold(record price) to oil (over $100 barrel despite nuclearpower’s woes) remain on the rise, while the DowJones index of 19 commodity markets recorded a firstquarter increase of 4.4 percent. Liam Pleven, Oil,Back at $100, Casts Long Shadow, WALL ST. J.,Apr. 1, 2011.

Most economists expect food prices to keepincreasing in 2011 and the United Nations Food and

Agriculture Organization said world food prices havealready risen to their highest point since 1990, whenthe FAO first began tracking prices. The UnitedNations is expecting high prices in developing nationsthat depend upon grain imports, with its “food priceindex” tracking at 32 percent higher from June toDecember 2008 (William Neuman, U.N. Notes SharpRise in World Food Prices, N.Y. TIMES, Jan. 6, 2011,at B1).

In the United States, leading agricultural economistsstudying this issue had suggested that trouble wouldarise from fundamentals in supply and demand forsoybeans and corn. Darrell Good, a University ofIllinois researcher, reported on the state of productionand demand at a “farm profitability” session inChampaign, Illinois, earlier this year. He reported thatcorn and soybean prices moved higher over the last sixmonths of 2010, getting closer to the high levels seen in2008. Dr. Good predicted a record high average U.S.price of $5.20 for corn this year, with soybeans at a$11.45 average price—this is over 10 percent higherthan 2008. As of the publication of this article,soybeans were trending at $13 per bushel, and corndroughts in Russia last year and currently in Argentina(e.g., 20 percent less corn) will make supplies of keycommodity grains scarcer, and price pressures willincrease even with high levels of production in theUnited States. Australia’s flood could hamper itsproduction, as well as water scarcity there. In short,there is justifiable concern that political instability couldlead to more reports of food riots in developingcountries. In 2008, over 20 nations reported suchunrest—this will be an issue to watch in 2011–2012.See, e.g., VOA, 2 Killed, Hundreds Injured inAlgerian Food Riots (Jan. 8, 2011), http://www.voanews.com/english/news/Two-Killed-Hundreds-Injured-in-Algerian-Food-Riots-113133109.html.

While the earthquake in Japan might hold lower oilprices steady for a month or two, and food priceincreases have slowed as this article was going topress, the future remains uncertain. Japan is already abig oil consumer. As the country begins to rebuild laterthis year, it will need more energy to rebuild and tomake up for power lost due to damaged nuclear

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facilities, which could push up prices further. Theturmoil in the Middle East is a major reason thatmotorists are facing higher gas prices and it shows nosigns of slowing in 2011. AP Steep Rise, supra.Biofuel policies are also a potential factor in prices—one driver of price is the credits for ethanol andbiodiesel, which were extended in 2010. In the EU, theRenewable Energy Directive entered into force andGermany’s aggressive implementation will drive moreuse of food crops for biofuels. The renewable fuelstandard is also driving higher levels of food cropsdiversion to biofuels, and Congress will need to makesome decisions about mandates that can only be metby using food crops. If U.S. ethanol plants are using 50percent more U.S. corn by 2016, will corn productionkeep pace? Production reportedly kept pace withdemand in 2008, with breeding and agronomyproviding 25 percent more corn, at a time whenethanol plants used 25 percent of the supply—butprices still spiked, in part due to speculation in futuresmarkets.

Since 2008, the demand for ethanol feedstock (corn)increased by 17 percent in September–December2010, when USDA projected 5.1 percent (see DarrellGood, supra). Corn stocks are as low as they havebeen in 15 years, and depending on the amount of cornproduced in 2011 in the United States, these stocksmay remain low.

As this food price issue evolves, the questions relatingto policies will necessarily resurface. This newsletterwill continue to report on the evolution of policiesrelating to such high food prices, so stay tuned.

Thomas P. Redick practices law as GlobalEnvironmental Ethics Counsel in St. Louis,Missouri, and acts as newsletter coordinator forSEER, in addition to editing the AgriculturalManagement Committee Newsletter (e-mail:thomasredick@netscape.net).

Environmental Aspects of Real Estate andCommercial Transactions: FromBrownfields to Green Buildings,Fourth EditionJames B. Witkin, Editor

A unique and practical resource, this updatedfourth edition examines entire range ofenvironmental issues that arise when realestate is developed, operated, sold, orfinanced.

This clearly written, detailed, and timely bookcovers all aspects of the environmentalissues that must be considered in thepurchase, sale, or finance of office, retail,manufacturing, or multifamily properties. Its29 chapters are organized into five parts forquick access to pertinent information:

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LIABILITY AND REDRESS: THESUPPLEMENTARY PROTOCOL TO THE

CARTAGENA PROTOCOL ON BIOSAFETY

Betty Kiplagat

Introduction

The Nagoya-Kuala Lumpur Supplementary Protocolon Liability and Redress to the Cartagena Protocol onBiosafety (Biosafety Protocol) was agreed to by theFifth series of the Conference of Parties serving as theMeeting of Parties (COP/MOP 5) in Nagoya, Japan,in October 2010. The Supplementary Protocol wasdeveloped to address Article 27 of the CartagenaProtocol, which called for the elaboration ofinternational rules and procedures in the field of liabilityand redress for damage resulting from transboundarymovements of living modified organisms. PressRelease, Convention on Biological Diversity, “ TheNagoya–Kuala Lumpur Protocol on Liability andRedress for Damage Resulting from Living ModifiedOrganisms born in Nagoya” http://www.cbd.int/doc/press/2010/pr-2010-10-12-nklp-en.pdf . TheSupplementary Protocol is open for signature fromMarch 7, 2011 to March 6, 2012, and shall enter intoforce on the 90th date after the date of deposit of the40th instrument of ratification, acceptance, oraccession.

This policy brief discusses some salient provisions ofthe Supplementary Protocol and highlights some of thechallenges the Parties faced in negotiating theSupplementary Protocol.

Administrative Approach for AddressingDamage from LMOs

The Supplementary Protocol (SP) establishes anadministrative approach for addressing liability andredress concerns relating to living modified organisms(LMOs). An administrative approach does notnecessarily involve adjudication by the courts. Allmatters are dealt with administratively—usually by adesignated national competent authority or regionalbody delegated to act by several national competentauthorities. The aim is to ensure fast and adequatepreventive response and remedial measures where

there is damage caused by LMOs. The approachoperates at the national level and gives the nationalauthority the competence to directly address operatorsresponsible for activities that pose a threat to theenvironment. The competent authority may request theoperator to provide information on imminent threats tothe environment in order to take preventive action orremedial action if damage has already occurred. Theapproach also allows for intervention before damagehas occurred. Under the administrative approach, thecompetent authority may take the necessary measuresitself and seek compensation for the costs from theoperator.

Civil Liability

During the negotiations, Parties agreed to develop alegally binding SP based on an administrative approachincluding a provision on civil liability. Civil liability is theliability of an entity for damage sustained by anotherprivate entity. Civil liability is governed by internal ornational law, and claims are brought before a nationalcourt by the private entity that suffered the damage.

It had been argued by some Parties that there was aneed to develop internationally binding civil procedurein the context of LMOs that would create uniformity asit was noted that courts of different countries havedifferent civil procedure rules. Parties that opposed theformulation of internationally binding civil proceduresargued that most of the member states already had inplace civil rules and procedures within theirjurisdictions, and therefore there was no need to createinternationally binding procedures.

After protracted negotiations, it was agreed that Article12 states that parties shall provide for responsemeasures relating to damage to biodiversity by LMOsin their domestic law by either applying existingdomestic laws and/or by developing civil liability rulesand procedures specifically for this purpose. Whendeveloping a domestic civil liability regime, each partywill in accordance with their domestic law addressissues relating to damage, standard of liability, includingstrict or fault-based liability, channeling whereappropriate, and right to bring claims. (Legalchanneling means that liability is exclusivelyconcentrated and allocated to a predefined party.)

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Definition of Damage

The definition of “damage” was central in thenegotiations. During the negotiations, some Partiespreferred a broad and inclusive definition while otherspreferred a simple definition. The broad definition itwas argued would include matters relating tosustainable use of biological diversity, conservation ofbiological diversity, costs of preventive and responsemeasures, socioeconomic considerations, traditionaldamage, and human health. (Traditional damageincludes death, personal injury including negativeimpacts on health, and damage to property andeconomic interests.) Those who preferred a simpledefinition proposed that the definition of damageshould be limited to damage to biological diversity (ordamage to the conservation and sustainable use ofbiological diversity) and damage to human health—butonly to the extent that it arises from adverse effects onbiological diversity.

After protracted negotiations, Parties agreed to acompromise between the two positions and defineddamage as an adverse effect on the conservation andsustainable use of biological diversity, taking also intoaccount risks to human health. The damage has to bemeasurable or otherwise observable and significant.The process of determining whether damage hasoccurred should wherever possible take into accountscientifically established baselines that are recognizedby a competent authority and should also take intoaccount any human-induced or natural variations. Thedetermination of a “significant” adverse effect will bedetermined by factors such as long-term or permanentchange; the extent of the qualitative or quantitativechanges that adversely affect the components ofbiological diversity; the reduction of the ability ofcomponents of biological diversity to provide goodsand services; and the extent of any adverse effects onhuman health in the context of the SupplementaryProtocol.

Definition of “Operator”

The definition of “operator” was also highly contentiousbecause it dealt with the channeling of liability. The SPdefinition of “operator” is broad and includes thepermit holder, the person who placed the LMO on the

market, the developer, the producer, the notifier, theexporter, the importer, the carrier, or the supplier. Thislist is indicative of possible operators that should bedetermined at the national level, thus Parties canprovide a definition that is more or less inclusive in theirdomestic law when implementing the SP. During thenegotiations, there was a clear divide on whether thedefinition should be narrow, so that only thoseresponsible for the risk assessment can be held liable,or broad, to include every person in the supply chain.It was felt that a broad definition targeting normalcommercial activities could inhibit trade and utilizationof crop technology. Conversely, others felt it wasessential that damage stemming from all aspects oftransboundary movements of LMOs be covered,whether the damage occurs at the transit, handling, orusage stage. It was, however, decided that thedefinition of operator should include both the person indirect and indirect control of the LMO. This wasunderstood to capture both the person that is inoperational control of the LMO when the responsemeasures are required (e.g., the carrier) as well as theperson responsible for damage due to the intrinsicproperties of the LMO (i.e., the developer orproducer).

Scope

The SP applies to living modified organisms intendedfor direct use as food or feed, or for processing;destined for contained use (for example, for research ina laboratory); and those intended for intentionalintroduction into the environment.

During the negotiations, it emerged that the Parties haddifferent understandings of the contentious “productsthereof” that were not included in the Protocol—e.g.,processed materials made from living modifiedorganisms, such as corn oil from genetically engineeredcorn. While mention of “products thereof” waseventually removed from the operative text of the SP,the report of the meeting recorded an understandingthat Parties may apply the SP to damage caused byprocessed materials that are of living modifiedorganism origin, provided that a causal link isestablished between the damage and the LMO inquestion.

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The compromise to record the understanding in thefinal report of COP/MOP 5 was important as itallowed for the exclusion of “products thereof” in thescope of the SP.

Financial Security

The right of Parties to provide for financial security intheir domestic laws is enshrined in the SP. Financialsecurity ensures that, if for any reason, the responsibleparty cannot pay for the damage caused by an LMO,there will be some alternative means available to do so.To this end, Article 10 provides that Parties retain theright to provide for financial security in their domesticlaw. Any provision of financial security should beconsistent with the Parties’ rights and obligations underinternational law. The Supplementary Protocol furtherprovides that Parties shall request the Secretariat toundertake a comprehensive study on matters relating tofinancial security.

The Compact

In response to Article 27 of the Cartagena Protocol,CropLife International, a group of six leading plantbiotechnology companies, including BASF, BayerCropScience, Dow Agrosciences, DuPont, Monsanto,and Syngenta, presented the Compact as an alternativemechanism to the development of a liability and redress

regime. The Compact is a binding contractual voluntaryprivate sector mechanism that will remedy actual“damage to biological diversity.” The Compact cameinto effect in 2010 and during the negotiations theparties agreed to note in the report the initiative by theprivate sector concerning recourse in the event ofdamage by LMOs.

Conclusion

The adoption of the Nagoya-Kuala LumpurSupplementary Protocol marks a milestone for theParties to the Biosafety Protocol. It establishes anadministrative procedure for addressing damage tobiological diversity caused by the transboundarymovement of an LMO. In preparing to ratify thisSupplementary Protocol, Biosafety Protocol Partiesshould note that domestic law will be central to theimplementation of that administrative approach. It istherefore important that Parties undertake acomprehensive review of laws relating to liability andredress within their respective jurisdiction as this willform the basis for implementing the requirements of theSP at the national level.

Betty Kiplagat is the legal program/policy officerat NEPAD/African Biosafety Network (e-mail:bkiplagat@gmail.com).

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LITTLE FISH, BIG PROBLEM:ENDANGERED FISH IMPACTS LARGE-

SCALE WATER DELIVERIES

Mia S. Brown

Two-thirds of California’s population and severalmillion acres of farmland rely on surface water thatpasses through, and is exported from, the San Joaquin-Sacramento Delta (Delta), which begins in theSacramento area of northern California, and terminatesin the San Francisco Bay. The Delta is the largestestuary system on the West Coast of the United States,consisting of numerous islands surrounded by over 700miles of waterways, and provides habitat for over 750species of plants and animals. Some of these speciesare endangered and measures to protect them haveresulted in restrictions on water exports, sparking whaton the surface appears to be a “fish vs. farmers”controversy that continues to play out in federal court.

The central and southern regions of California are arid,and rely primarily on deliveries of water from twomajor water storage and conveyance systems, theCentral Valley Project and the State Water Project,both of which divert water through enormous pumpingfacilities located at the southern end of the Delta. TheCentral Valley Project (CVP) is operated by thefederal government through the U.S. Bureau ofReclamation, and is California’s largest water supplier.It delivers on average over 7 million acre-feet of waterper year to irrigate three million acres of farmland in theCentral Valley, as well as provides the urban watersupply for several surrounding counties. The StateWater Project (SWP) is the largest state-built waterand power project in the United States. Its systemreaches 600 miles from northern to southern California,and provides drinking water for 23 million people andirrigation water for 750,000 acres of farmland.Collectively, CVP and SWP are referred to as the“projects” in this article.

The Delta smelt (Hypomesustranspacificus) is one ofa number of endangered plant and animal species thatlive in the Delta. The Delta smelt is small (2.5 inches)and smells like fresh-cut cucumbers. Once abundant,the smelts’ number began to decline in the 1970s, dueto large-scale pumping from the projects. The smelt

was listed as a “threatened species” under theEndangered Species Act (ESA) in 1993, and is now“endangered” and facing extinction. While the smelthas no commercial value as a baitfish or otherwise, it isone of the “indicator species” revealing the Delta’sbiological and environmental health.

When the projects’ pumps operate, they create a drawso powerful that two rivers within the Delta interiorreverse their flow. While fish-screening facilities areused, the collective operation of the projects’ pumpskills Delta smelt and other ESA-listed species (e.g.,various salmonids, the Central Valley steelhead, andgreen sturgeon).

In 2005, the U.S. Fish and Wildlife Service (FWS)released a biological opinion (BiOp) regarding theimpact of the projects’ operations on Delta smelt andresident salmonid species. The USFWS BiOpconcluded that continued operation of the projectswould not be detrimental to the continued existence ofthe Delta smelt.

In December 2006 the California SportfishingProtection Alliance, a nonprofit organization thatadvocates on behalf of California fisheries, filed suit infederal court challenging the 2005 BiOp and allegedthat the SWP’s entrainment of fish was an unlawful“take” (kill) of Delta smelt under the ESA , since theproject’s operators lacked the requisite permits fromthe California Department of Fish and Game.

In mid-2007, federal Judge Oliver Wanger (U.S.District Court for the Eastern District of California)addressed the 2005 FWS BiOp, finding it failed toanalyze significant information and rendering thedecision “arbitrary, capricious, and contrary to law.”Judge Wanger directed FWS to revise the BiOp, andin the interim, required reductions in Delta waterexports during January through June when the pumpingmost adversely affected the smelt. As a result, watercontractors were told to expect only 35 percent oftheir 2008 water allocations.

FWS released its revised BiOp in 2008, finding thatongoing operations of the projects would jeopardizethe Delta smelt and adversely affect its critical habitat.Pursuant to the ESA, the BiOp imposed a “reasonable

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and prudent alternative” (RPA), which includednumerous changes to the projects’ operations that, ifimplemented, would reduce water deliveries toprojects contractors by thousands of acre-feet peryear. In response, numerous public water agencies,districts, and other projects water contractors, as wellas the state of California (through the Department ofWater Resources), sued FWS and the U.S. Bureau ofReclamation, alleging violations of the ESA, theAdministrative Procedure Act (APA), and the NationalEnvironmental Policy Act (NEPA), collectively calledthe Delta Smelt Consolidated Cases (Document#757, Lead Case No. 1:09-cv-00407-OWW-DLB,E.D. Cal. Mar. 3, 2009). A similar class of cases hasalso been consolidated regarding the BiOp and mattersrelating to projects’ operations and their impact onDelta salmonid species (Case No. 1:09-cv-01053-OWW-DL, E.D. Cal. June 15, 2009).

In 2009, the state entered its third consecutive year ofdrought, and water contractors were informed thatthey could expect further reduced water deliveriesfrom the projects. On May 31, 2009, the exportpumps were briefly shut off all together (though exportscommenced June 1), drawing national attention.Disgruntled water contractors launched a massivepublic relations campaign decrying the situation as a“Congress-created dustbowl,” and alleging thatprotection of a commercially valueless minnow wouldbring California’s billion-dollar agricultural industry toits knees. Fields were fallowed, almond and otherorchards were uprooted, creating a dramatic backdropfor roadside signage blasting the federal governmentfor creating modern-day “grapes of wrath” conditionsin the Central Valley.

Conservative talk show host Sean Hannity (FoxNews) did a live broadcast from Fresno County, aCentral Valley region that relies heavily on waterexported from the Delta, showing the purported“devastation” wrought by reduced water deliveries,including displaced farmworkers at the local foodbank, dry and dusty fields, and protesters demandingthat President Obama “turn the pumps back on.” Themedia coverage attributed the plight of the CentralValley to the export reductions imposed by the BiOpand Judge Wanger’s decisions. What received littleattention, however, was that export reductions for

2009 were only 25 percent attributable to restrictionsand 75 percent due to drought, according to the state’sDepartment of Water Resources. In reality, 2009 wasa relatively normal year for water use, and whileFresno County farm revenues experienced a decline in2009, it was only by 4.5 percent according to thecounty’s annual crop report released in June of 2010.Also ignored was the impact that Delta pumpingschedules had on salmonid species and the recreationaland commercial salmon fishing industries in northernCalifornia, which closed for much of the 2008 and2009 seasons.

In December 2010, Judge Wanger issued a 225-pageopinion on the 2008 FWS BiOp, placing blame on the“fish vs. farmers” water war waged in 2009. JudgeWanger found that the findings contained in the BiOpand the resultant flow requirements imposed by theRPA were “arbitrary, capricious, and unlawful,” forfailing to use the best available science as required bythe ESA. While the decision upheld the basicconclusion that export operations adversely affectsmelt, it directed FWS to revise the BiOp for failure to,among other things, consider the economic effects onfarmers and other businesses reliant on water deliveriesand explain how the RPA’s export restrictions protectsmelt populations better than less harmful alternatives.FWS must now return to the drawing board to addressthe deficiencies identified by the court. It is unclearhow export operations will be impacted in the interim.

On March 9, 2011, FWS announced a publiccomment period on longfin smelt through April 9,2011. FWS will review scientific, commercial, andother information on listing of the longfin smelt underthe Endangered Species Act (ESA). It expects to issuethe determination by September 30, 2011.

In a related matter on March 25, 2011, a panel of theU.S. Circuit Court of Appeals voted 3-0 to upholdJudge Wanger in the consolidated smelt cases, holdingthat federal protection was proper under the ESA andthe Commerce Clause, even where a species residesonly in California with no commercial value (Steward& Jasper Orchards v. Salazar, 2011 DJDAR 4419).

California’s water issues are complex, and will continueto be litigated for the foreseeable future. It can be said

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(with tongue slightly in cheek) that the Delta smelt, alittle cucumber-scented baitfish, has California waterstakeholders in a bit of a pickle.

Mia Brown practices water, agriculture, and publicagency law with the firm of Neumiller & Beardsleyin Sacramento, California. She can be reached atmbrown@neumiller.com.

Editor’s Note: At the Salt Lake City meeting,Cynthia Koehler of the Environmental DefenseFund presented a paper on the “public trust”doctrine as applied to California’s water wars,which is available online at http://www2.americanbar.org/calendar/40th-annual-conference-on-environmental-law/Meeting%20Materials/postprogram/Koehler_wm_ACEL2011.pdf.

THE ROLE OF BIOTECHNOLOGY INSUSTAINABLE AGRICULTURE

Brandon W. Neuschafer

For thousands of years, human ingenuity has resulted inbetter and better seed stock through breeding. Wehave learned to breed certain desirable traits into seedwhile at the same time breeding undesirable traits outof seed. In the mid-1990s, however, the entire face ofagriculture changed with the introduction of crops usingrecombinant DNA (biotechnology) to make plants thatresist pests and herbicides, or possess other beneficialtraits. Such crops and animals are called “geneticallymodified organisms” (GMOs) by activists and someregulatory agencies in foreign markets, but will becalled “biotech crops” for this article. Withbiotechnology, innovators can transform seed toinclude traits such as herbicide tolerance or insect ordisease resistance, or introduce beneficial traits such asdrought tolerance.

Biotech crops are most often used for food, feed, orfiber production, but certain traits can be designed forindustrial uses, for example, corn with enzyme toenhance ethanol production. Although one traditionallythinks of biotech crops with respect to row crops andvegetables, food sources such as biotech salmon andpigs are also in development stages. Biotech traits arebecoming more varied, with traits such as droughttolerance, heat tolerance, and salinity tolerance in thepipeline. Indeed, drought-tolerant biotech maize isexpected to reach the market within the next five years(Dupont is marketing traditional drought tolerance traitsin corn while the biotech trait awaits USDA approval).See Seed Companies Set for Corn Hybrid War withDrought-Tolerance Traits?, Jan. 25, 2011 (“Theduo’s entry into the world market could start decadesof fierce competition for rain-challenged growers’business. Biotech varieties in the pipeline for futurerelease may have an even bigger impact than today’shybrids.”), available at http://cornandsoybeandigest.com/seed/seed-companies-set-corn-hybrid-war-drought-tolerance-traits (last visited Mar. 26, 2011).

Other traits being developed include a modification ofphotosynthetic cycles to reduce carbon releases and tocreate a nitrogen fixing trait that would reduce fertilizer

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inputs (and the concomitant costs and environmentalimpacts from fertilizer production and use).Biotechnology is not just looking at new traits in majorcrops, but also more varied and minor crops, includingpotato, bananas, eggplant, tomato, broccoli, cabbage,cassava, papaya, sweet potato, pulses and groundnuts.

According to the nonprofit International Service for theAcquisition of Agri-Biotech Applications, plantings ofbiotech crops in 2010 increased 35 percent to 365million acres. More than 15 million farmers in 29countries representing 59 percent of the world’spopulation planted biotech crops. Developing countriesaccount for 48 percent of these crops, and areexpected to plant more biotech crops thatindustrialized nations by 2015. More than 90 percentof the total number of farmers (14.4 million) weresmall-scale farmers, representing some of the poorestpeople in the world.

Despite opposition from many consumer andenvironmental groups (particularly outside the UnitedStates), biotech crops enjoy broad support fromgovernments and growers. China, Brazil, India andmany other countries are beginning to embracebiotechnology. According to Pioneer, some Asiancountries like Indonesia, Vietnam, and Cambodia areencouraging seed companies to register products there.Even traditional opponents, such as the EU, arebeginning to change their course. Recently, theEuropean Commission recognized that GMO cropsare at least as safe for consumers and the environmentas conventional crops, and that biotechnology couldhelp developing countries meet food pressures.

There are many reasons for this shift in attitude,including costs of production, yield, and the lack of anydocumented adverse health effects after 15 years ofexperience. But perhaps one of the most significantdriving forces is recognition of the benefits thatbiotechnology can provide to a quickly rising andincreasingly hungry population. Conventionalagriculture alone does not provide a sustainable modelfor feeding this population, and biotechnology providesa critical, sustainable tool to help combat increasingfood needs.

The global population is expected to increase from 6.8billion in 2009 to nine billion in 2050. Food demandwill increase during the same time frame between 70percent and 100 percent. The United Nations Foodand Agriculture Organization (FAO) predicts morefood shortages in 2011. While demand is up, foodprices are similarly rising. FAO estimates that over thelatter half of 2010, the food price index increased 32percent. February 2011 saw record food prices.

Food production is becoming an increasingly moreexpensive production, both in direct costs such as fueland indirect costs through the production and use ofproducts such as fertilizers. And while food demandmay double over the next 40 years, clearly the amountof land available for cultivation will not expand bysimilar factors. By one estimate, the amount of arableland will decrease from 0.62 acres per person in 1999to 0.37 acres per person in 2050. (In 1966, it was1.11 acres per person.)

The end result is that our production efficiency needsto increase. We have to do more with the land andresources we have, lest we see even larger-scaledestruction of forested areas for cropland. This oftenmeans selecting the best seed with the best traits forthe area, taking into account pest pressures and theneed for certain quality traits, as well the bestagronomic practices. While biotech crops may not bea perfect fit for every field or end consumer, they arecertainly a critical tool in sustainably feeding the world.

So how do biotechnology and biotech crops fit into theconcept of sustainable agriculture? We need toincrease yield, but we must also take into accountenvironmental and social factors in order to besustainable. Each of these concerns will be exploredhere independently. First, biotechnology improvesyields. For example, insect-resistant crops (known asBt crops, for Bacillus thuringiensis) deliver averageyield increases around 6 percent for corn and 11percent for cotton. In developing countries, yields aresignificantly higher. Bt cotton in India has increasedyields 50 percent, and Bt corn in the Philippines hasincreased yields 24 percent. These yield gains can beattributed not only to the Bt seed itself, but also betteragronomic practices. The important point is that thereare significant yield benefits to be gained in developing

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countries, and biotechnology will play a crucial role inrealizing those gains.

In 2010, professor Wayne Parrott of the University ofGeorgia published a paper regarding yield benefits andsustainability of biotechnology. Among other things,professor Parrott compared crops that were largelybiotech by 2007 (corn, cotton, and soybean) againstwheat, which was entirely non-GMO. He comparedchanges of certain sustainability-related factorsbetween 1987 and 2007, including yield increases,decreases in land per bushel or pound, decreases insoil loss per bushel or pound, decreases in energy useper bushel or pound, and decreases in greenhouse gasemissions per bushel or pound. On every indicator,each biotech crop performed significantly better thanthe non-GMO crop.

As professor Parrott concluded, while improvements inconventional agricultural practices alone may helpyield, they won’t provide the necessary output on theirown. Nor will organic practices provide the yieldsnecessary to feed the expanding population. Organiccorn and soybean production in the United Statesconsistently demonstrate yields 20–30 percent lowerthan conventional methods, and evidence of productionoutside the United States is consistent with thesenumbers. Yield is not the end of the story;environmental impacts must also be considered.Importantly, we need to consider net environmentalimpacts and not focus on any single indicator.

The charge often levied against biotech crops is thatalthough they may decrease the use of certain classesof pesticides (for example, decreased insecticide usedue to insect resistance), they increase the use of otherclasses of pesticides, particularly herbicides. However,recent numbers published by EPA show that total U.S.pesticide use decreased 8 percent from 2000 to 2007,years that saw an explosion in the use of biotech crops.During the same period, total pounds of herbicideapplied to U.S. crops actually decreased by 2 percent,and organophosphate pesticide use (insecticides)decreased 63 percent. Additionally, one cannot ignorethat even if herbicide use increases, such herbicidesgenerally pose significantly fewer human health andenvironmental concerns than potentially more toxicinsecticides.

One significant benefit that biotech crops have broughtto agriculture is more environmentally friendlyagricultural practices, such as the increased ability touse low- or no-till farming. Such methods provide forbetter erosion control, decreased fuel and energyconsumption, and decreased water usage. By someestimates, the reduced fuel use alone in 2007 resultedin carbon emission reductions equivalent to removing6.3 million cars from service for an entire year. Lessplowing also allows the soil to act as a carbon sink,reducing carbon dioxide emissions. Higher yields andincreased efficiency could also result in fewer acres offorestland being cleared for crop or pasture usage,which has significant biodiversity and carbon reductionbenefits of its own.

Various sustainable agriculture standards are taking onthe question of whether biotech crops and organic cancoexist, with each seeking to define a sustainableproduction process. This includes a proposed nationalstandard on sustainable agriculture (ANSI SCS-001)that began as organic and became more “science-based” after USDA and various conventional farmersintervened. See Thomas P. Redick, Shawna M. Bligh& James Andreasen, Report on ANSI’s DraftNational Standard for Sustainable Agriculture, 14A.B.A. SEER AGRIC. MGMT. COMM. NEWSLETTER at16, available at http://apps.americanbar.org/environ/committees/agricult/newsletter/archiveslist.html. Otherstandards overseas may favor organic productionmethods (see, e.g., the European Union’s Global GAPstandard) or discriminate in subtle ways against biotechcrops. Global GAP is a nongovernmental organizationthat sets voluntary standards for the certification ofagricultural products around the globe. Formerlyknown as EUREPGAP (for European GoodAgricultural Practice), this standard strives forworldwide harmonization of sustainability standards.As such, an existing sustainability standard can seek tobe recognized as equivalent, provided it meets therequirements. This standard reflects the European biasagainst biotech crops by, among other things, requiring“a plan for handling GM material (crops and trials)setting out strategies to minimise contamination risks,such as accidental mixing of adjacent non-GM cropsand maintaining product integrity.” See CB. 2. 5. 4. atGlobal GAP (2011), Control Points and ComplianceCriteria Integrated Farm Assurance at p. 5, available

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at http://www.globalgap.org/cms/upload/The_Standard/IFA/Version_4_2011/Final_V4/Documents_clean/110420_gg_ifa_cpcc_cb_eng_final_v4.pdf

Many propose organic farming as a moreenvironmentally friendly alternative to biotechnologyand conventional cropping systems, but on a largescale, the sustainability of organic methods isquestionable. Not only do organic crops suffer fromyield drops (meaning the land used for production isless efficient), but nutrient inputs in terms of fertilizercould be costly. We would need substantially increasedsources of nutrients (generally manure), and there aresignificant environmental costs associated with theproduction and transportation of those nutrients.

Biotechnology also provides social benefits, animportant consideration for sustainability. As indicated,nearly half of all biotech crops planted in 2010 were indeveloping countries. In the first 11 years of their use,the incomes of over 10 million farmers who adoptedbiotech crops increased by a total of between $34 and46 billion. In developing countries, average householdincomes of farmers increased up to 33 percent. InArgentina, it is estimated that the introduction ofbiotech crops and subsequent no-till methods allowedfor the creation of 200,000 jobs, primarily focused onproviding new and improved equipment and sources ofagricultural inputs. These reductions in fuel use, wateruse, and chemical inputs, coupled with increased yieldpotential, mean higher profits and improved quality oflife. Additionally, biotechnology and improved croppingpractices allow for the mitigation of certainenvironmental stressors, which could result in moreyearly plantings in a rotational system. More plantingsgenerally mean more profits and higher and moreconsistent employment.

But the benefits are not solely economic. For example,Bt corn reduces the formation of carcinogenicmycotoxins, an unforeseen benefit. Moreover,researchers are also looking at traits to improvenutrition levels in food. A classic example is “goldenrice,” which has high levels of vitamin A to combatvitamin A deficiency, which afflicts over 120 millionpeople and causes up to two million deaths per year.

The foregoing is not by any means intended to be anexhaustive discussion of all of the factors demonstratingthe sustainability of and need for biotechnology to faceour agricultural hurdles. Nor is it to suggest thatbiotechnology is the answer to all of our problems, orthat we should in any way abandon rigorous, science-based regulation of biotech crops. Biotechnology is atool that, along with improved agricultural practices,we must maintain in our arsenal to combat hunger andmalnutrition. It should not and does not need todisplace organic production, but organic production(which in the United States represents 0.57 percent offarmland, according to USDA) cannot be the driver ofglobal food and agricultural policies to the exclusion ofbiotechnology.

Brandon W. Neuschafer is a partner with BryanCave LLP in St. Louis, Missouri. He can be reachedat bwneuschafer@bryancave.com.

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HOW TO FEED THE WORLD IN 2050? THENEED FOR ORGANIC AND SUSTAINABLE

FARMING SYSTEMS

Martha Noble

According to the U.S. Census Bureau, the world’spopulation increased in just 80 years from 3.2 billion in1930 to the current level of 6.9 billion, an increase of3.7 billion people. By 2050 the world population isprojected to increase by 2.4 billion to a total of 9.3billion people. U.S. Census Bureau, InternationalDatabase, available at http://www.census.gov/ipc/www/idb/worldpoptotal.php. This burgeoningpopulation will increase the demands on worldresources that are already under heavy stress, includingfreshwater and arable land, in order to providesufficient food production to achieve food security.

There are two commonly used definitions of foodsecurity. The United Nations (UN) Food andAgriculture Organization (FAO) defines food securityat a national or global level as including the followingset of conditions: food security exists when allpeople, at all times, have physical, social andeconomic access to sufficient, safe and nutritiousfood to meet their dietary needs and foodpreferences for an active and healthy life. See UNFAO, Food Security Statistics, available at http://www.fao.org/economic/esess-fs/en/. The U.S.Department of Agriculture (USDA) defines foodsecurity for a household as “. . . access by allmembers at all times to enough food for an active,healthy life. Food security includes at a minimum(1) the ready availability of nutritionally adequateand safe foods, and (2) an assured ability to acquireacceptable foods in socially acceptable ways (thatis, without resorting to emergency food supplies,scavenging, stealing, or other coping strategies).”See USDA Economic Research Service, FoodSecurity in the United States: Measuring HouseholdFood Security, available at http://www.ers.usda.gov/Briefing/FoodSecurity/measurement.htm#what. Both ofthese definitions include basic, adequate nutrition andfood safety, with the UN definition also including foodpreferences.

A third more comprehensive definition of “communityfood security,” developed by Mike Hamm and AnneBellows, is used by the Community Food SecurityCoalition: “Community food security is a conditionin which all community residents obtain a safe,culturally acceptable, nutritionally adequate dietthrough a sustainable food system that maximizescommunity self-reliance and social justice.” SeeCommunity Food Security Coalition, What IsCommunity Food Security?, available at http://www.foodsecurity.org/views_cfs_faq.html. Thedefinition and an accompanying set of principles for thedefinition include attention to the methods by which thefood is produced and the importance of maximizing theproduction of local foods as part of food security.

This point-counterpoint essay addresses the questionof whether organic and sustainable farming systems canmeet the food security needs of the global populationpredicted for 2050. For purposes of the essay, allthree definitions of food security are relevant, includingthe community definition that emphasizes theimportance of farming and food systems that aresustainable over the long term and include attention tothe economic and social welfare of communities.

The U.S. National Organic Program regulations define“organic production” as “a production system that ismanaged in accordance with the [NationalOrganic] Act and regulations in this part torespond to site-specific conditions by integratingcultural, biological, and mechanical practices thatfoster cycling of resources, promote ecologicalbalance, and conserve biodiversity.” 7 C.F.R. §205.2.

As described by the USDA’s Sustainable AgricultureResearch and Education (SARE) program, organicfarming entails:

• “Use of cover crops, green manures, animalmanures and crop rotations to fertilize the soil,maximize biological activity and maintain long-term soil health.

• Use of biological control, crop rotations andother techniques to manage weeds, insects anddiseases.

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• An emphasis on biodiversity of the agriculturalsystem and the surrounding environment.

• Using rotational grazing and mixed foragepastures for livestock operations andalternative health care for animal wellbeing

• Reduction of external and off-farm inputs andelimination of synthetic pesticides and fertilizersand other materials, such as hormones andantibiotics.

• A focus on renewable resources, soil andwater conservation, and management practicesthat restore, maintain and enhance ecologicalbalance.”

USDA Sustainable Agriculture Research andEducation (SARE), Transitioning to OrganicProduction at 2 (2006), available at http://www.sare.org/Learning-Center/Bulletins/National-SARE-Bulletins/Transitioning-to-Organic-Production).

Congress recognized the benefits of organic farmingsystems in the 2008 Farm Bill with numerousprovisions to promote organic production. Keyprovisions were included in the Farm Bill’sconservation programs to provide organic farmers withresources to establish many sustainable practices andsystems that can increase the positive environmentalperformance of organic farms. One measure is anorganic initiative in the Environmental QualityIncentives Program (EQIP) that provides cost-shareassistance and technical assistance to farmers whowant to transition into organic farming or organicfarmers who want to bring more land into organicproduction or add organically raised animals to theirfarming system. 16 U.S.C. § 3839aa-2(i). In addition,in the Conservation Stewardship Program (CSP) theUSDA secretary is directed to develop an organic“crosswalk” that will facilitate the use of the CSP forfarmers transitioning to organic farming systems. 16U.S. C. § 3839f(h). The USDA secretary is alsodirected to ensure that outreach and technicalassistance are available and CSP programspecifications are appropriate to enable specialty cropand organic producers to participate in the program.16 U.S.C. § 3839g(c).

The global organic community, embodied in theInternational Federation of Organic Movements hasadopted four principles to guide the development oforganic agriculture. These principles extend beyond theorganic farming system to also include criticalcommunity and social values, including:

• Principle of Health: organic agriculture shouldsustain and enhance the health of soil, plant,animal, human and planet as one andindivisible.

• Principle of Ecology: organic agriculture shouldbe based on living ecological systems andcycles, work with them, emulate them and helpsustain them.

• Principle of Fairness: organic agriculture shouldbuild on relationships that ensure fairness withregard to the common environment and lifeopportunities.

• Principle of Care: organic agriculture should bemanaged in a precautionary and responsiblemanner to protect the health and well-being ofcurrent and future generations and theenvironment

International Federation of Organic AgricultureMovements, Principles of Organic Agriculture,available at http://www.ifoam.org/about_ifoam/principles/index.html.

Organic farming systems are essentially agroecologicalsystems that focus on improving soil health, maximizingon-farm inputs, and farming system diversification. Thisis in contrast to an industrial based model of farmingthat relies heavily on purchased inputs and relativelysimplified farming systems, for example the currentcontinuous corn production that is found on millions ofacres of farmland in the United States. Organicagriculture is also an evolving system that incorporatesagricultural production advances that consistently yieldbenefits, including among others new varieties of crops,precision agricultural techniques, more efficientmachinery, and the use of new low-tillage methods ofweed control. But not all agricultural methods are used.

The standards for organic production are also underconstant scrutiny to minimize the use of inputs that have

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been shown to have significant negative impacts onsociety and the environment. Importantly, pesticidesthat result in environmental pollution or rapid pestresistance are avoided. Weed management iscontrolled by methods that also increase soil carbonand enhance soil fertility, including organic croprotations, cover crops, and natural-based products.Organic farmers do not use synthetic nitrogen fertilizer,relying instead on composted animal manures, theincorporation of green plant manures, and the use ofnitrogen-fixing legumes in crop rotations. They also usebiological, cultural, and physical methods to limit pestexpansion and increase populations of beneficialinsects on their farm. See Iowa State UniversityExtension, Fundamentals of Organic Agriculture(2003), available at http://www.extension.iastate.edu/Publications/PM1880.pdf.

From the perspective of organic farmers, geneticallymodified organisms (GMOs) constitute synthetic inputsthat pose unknown risks or identified risks that maketheir use counter-productive in the long run. Forexample, the majority of GMOs currently in use areherbicide-resistant crops that are linked to the use ofherbicides. A prime example is glyphosate-resistantcrops. In the first few years of their use, glyphosate-resistant crops in combination with low-till farmingsystems did decrease the use of more toxic pesticidesand the use of tillage in conventional farming systems tocontrol weeds. But from the beginning, glyphosate-resistant crops posed a problem in farming systemswith crop rotations. For example, a farmer plantingglyphosate-resistant corn in one season could findglyphosate-resistant corn plants popping as recruits ina field of soybeans or cotton in the next season.

A more serious problem is that as the acreage ofgylphosate-resistant crops increased, so did the use ofthe glyphosate pesticide, including the widespread useof aerial spraying of glyphosate. Not surprisingly alandscape awash with glyphosate is a strong selectivepressure on individual plants of weed species that hadresistance to glyphosate. See, e.g., Vijay K. Nandulaet al., Glyphosate Resistant Weeds: Current Statusand Future Outlook, OUTLOOKS ON PEST MGMT.,Aug. 2005, available at http://www.ars.usda.gov/SP2UserFiles/Place/64022000/Publications/Reddy/

Nandula-GRW12.pdf. The response of the GMOseed industry has been to incorporate into crop seedsgenetic traits for resistance to more toxic herbicides,with more expensive seeds now double or triplestacked with herbicide-resistant traits. In some regionsthat method is failing, with weeds emerging that areresistant to numerous pesticides. The result is thatsome weed management specialists are recommendingthe use of more toxic herbicides and the use of deepertillage to control weeds. For an overview of pesticide-resistant weed species on a state basis, see the NorthAmerican Herbicide Resistant Weed Survey, availableat http://www.weedscience.org/usa/statemap.htm. Theoverall result is a return to more toxic pesticidescombined with higher tillage, with farmers paying morefor seeds.

Insect-resistant GMO crops are also avoided byorganic farmers, in part because they are engineered tocontain pesticides that remain in the environment. Thiscan increase the probability of target insects developingresistance to pesticide. In addition, nontarget insectpopulations can also be affected, including beneficialinsects. The most common GMO system for insectresistance is the incorporation of a genetic trait from abacterium, Bacillus thuringiensis (Bt), which inducesthe plant to produce a toxin that kills a wide array ofinsect pests. Ironically, organic farmers have longcombined integrated pest management techniques suchas scouting for the presence of insect pests, withjudicious use of topical application of Bt toxin. Withjudicious use, Bt pest resistance to the toxin is lesslikely to develop. See, e.g., Colorado State UniversityExtension, Bacillus thuringiensis, available at http://www.ext.colostate.edu/pubs/insect/05556.html.

In recent years, organic farmers and organizations thatrepresent their interests have launched legal challengesto USDA’s approval of commercial release of GMOcrops on the grounds that the agency has failed toundertake a sufficient analysis under the NationalEnvironmental Policy Act of potential environmentalproblems arising from the widespread use of GMOcrops, including the social and economic harms arisingout of the environmental concerns. See, e.g., Centerfor Food Safety v. Vilsack (U.S. District Court forthe Northern District of California, Case No. CV 11

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1320, complaint filed Mar. 18, 2011), available athttp://www.centerforfoodsafety.org/wp-content/uploads/2011/03/1-Complaint.pdf, and other casescited in the case law update from Jillian Hishaw andTom Redick in this newsletter.

On March 29, 2011, the Public Patent Foundationfiled a lawsuit that challenges the validity of all thepatents granted to Monsanto’s transgenic seeds ongrounds that patents fail to satisfy requirements of theU.S. Constitution and the Patent Act. The plaintiffs inthe lawsuit are also seeking protection from being suedfor patent infringement if Monsanto’s transgenic seed isfound to have contaminated their land or crops. Theplaintiffs include sixty organic and sustainable tradeassociations and individual plaintiffs who are organicfarmers or ranchers. See Organic Seed Growers andTrade Association v. Monsanto Company andMonsanto Technology LLC (complaint filed in U.S.District Court, Southern District of New York, CaseNo. 11 CIV 2163), available at http://www.pubpat.org/assets/files/seed/OSGATA-v-Monsanto-Complaint.pdf.

The most recent USDA approval of a geneticallyengineered crop has generated resistance not only fromthe organic community but also from food processors.In February, USDA’s Animal Plant and HealthInspection Service approved for commercial use aGMO corn bioengineered by Syngenta with anamylase enzyme that digests starch in the corn tosugars. The corn, dubbed Enogen corn, can be usedonly by the corn ethanol industry, an industry thatbenefits from significant Farm Bill subsidies and afederal tax credit enabling more use of ethanol blendedwith gasoline. A small amount of the amylase containingcorn mixed into other corn can render that corn unfitfor feed or food uses. USDA released the Enogen cornfor commercial use with no required safeguards toensure that it would not intermingle with corn destinedfor other uses. Among others, the North AmericanMillers Association objected to the commercial releaseof Enogen® corn, without sufficient regulatorysafeguards to prevent it from intermingling with othercorn destined for food and feed uses. Syngentaacknowledged that the food processing industry will berequired to test its supply of corn for food uses, forcing

millers to cover the additional expenditure. See NAMADisappointed in USDA Approval of Petition toDeregulate Amylase Corn, posted on NAMA NewsFeb. 2011, available at http://www.namamillers.org/NewsArchives11/Feb11News.html#1.

In addition, the production of this corn, which isdirected to an industrial use, may significantly decreaseacreage for food production, including the productionof crops other than corn necessary for an adequateand nutritious diet. As Margaret Mellon, director of theUnion of Concerned Scientists Food and EnvironmentProgram stated, “The USDA has placed the interestsof the biotechnology industry over the interests of foodprocessors and the general public. The agency’spriorities are upside down. Food is far more importantthan ethanol. USDA needs to stop throwing the foodindustry under the biotechnology bus” (available athttp://www.ucsusa.org/news/press_release/usda-deregulates-ethanol-corn-501.html?print=t).With this perspective on organic and sustainableagriculture background, the question is whether thesefarming systems—based on agroecological models ofreducing manufactured inputs, increased diversity offarming systems to help provide and retain nutrients,break up pest cycles, and increase soil structure andhealth—can feed the world in 2050.

An important point in addressing this question is that ofwhere the largest percent increases in population areexpected by 2050. The estimate provided by thePopulation Reference Bureau is that Africa and otherless developed countries will have the largest percentincreases, followed by India and China, which retaintheir position as the two countries with the highestpopulations. The top 10 nations predicted to have thelargest percent increase are all in Africa.

In March 2011, the United Nations Human RightsCouncil released the Right to Food Report, whichconcluded that agroecological systems of agriculturehave proven results for fast progress in achieving foodsecurity for many vulnerable groups in variouscountries and environments. UN Human RightsCouncil, REPORT SUBMITTED BY THE SPECIAL

RAPPORTEUR ON THE RIGHT TO FOOD, (Dec. 20,2010), available at http://www.srfood.org/images/

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stories/pdf/officialreports/20110308_a-hrc-16-49_agroecology_en.pdf. An earlier 2007 report by theUN senior officer for Environment and Developmentconcluded more specifically that modern, innovativeorganic agriculture could play a significant role infeeding the world in 2050. See Nadia El-HaageScialabba, Organic Agriculture and Food Securityin Africa (June 2007), in Aksel Naerstad, Africa CanFeed Itself 214–29, available at http://www.ifoam.org/about_ifoam/around_world/aosc_pages/pdf/Africa_can_feed_itself.pdf.

The UN Right to Food Report is based on anextensive literature review in the last five years. A fullsummary of this report cannot be covered within thelimits of this brief newsletter essay, but the gist of thereport includes the following highlights drawn from thenews release issued with the report:

• Agroecology can enable small-scale farmers todouble food production using ecologicalmethods, within 10 years in regions with criticalfood needs;

• Agroecology is science based, drawing on theecological sciences to design agriculturalsystems, and the methods of agroecology canoutperform the use of chemical fertilizers inboosting food production where populationsfacing the most hunger live, especially inenvironments that are less favorable toagricultural production;

• Agroecological projects in have shown anaverage crop yield increase of 80 percent in 57developing countries with an average increaseof 116 percent for all African projects;

• One example of the application ofagroecological farming systems is Malawi. Thecountry initially launched a massive chemicalfertilizer program a few years ago but thenturned to agroecological systems that sawmaize yields increase from one ton per hectareto two to three tons per hectare.

News Release, UN Human Rights Office of the HighCommissioner, Ecofarming Can Double FoodProduction in Ten Years Says New UN Report (Mar.8, 2011), available at http://www.srfood.org/images/

stories/pdf/press_releases/20110308_agroecology-report-pr_en.pdf.

The report also found that in addition to helpingrehabilitate degraded land and increase overall yields,agroecological systems can help alleviate rural poverty.The use of on-farm fertility enhancements can reducefarmers’ reliance on external inputs and on governmentsubsidies. For example in Africa, the planting of treesthat fix nitrogen have helped farmers increase soilfertility while providing forage for livestock. Treespecies that shed their leaves during the growingseason for field crops do not compete for light ormoisture during the growing season. The report alsoemphasized that the increased diversity of farmingsystems also provided more rural employment andincome. This is critically important in India, China, andthe developing countries in Africa, where migrants fromrural areas are overwhelming theability of these countries to provide water, adequatefacilities for handling human and industrial wastes, andother services required in highly crowded cities.

The report concludes with a number ofrecommendations for other measures that can fosteragroecological farming systems, including increasingextension services for farmers in developing countries,reorienting public spending for publicly available goodsincluding an increase of public seed breeding programsfor a wide diversity of crops, with the seeds publiclyavailable and with farmers retaining the right of seedsaving. Measures will also be needed to increaseresearch that includes farmer participation, increasedaccess to credit, and an increased emphasis on thedelivery of credit and assistance to women.

The report joins a growing body of research andinformation about the ability of agroecologicalsustainable and organic systems to provide sufficientfood to meet the needs of the 9.3 billion peopleexpected to populate the world in 2050. The use ofthese systems will be necessary to achieve foodsecurity in 2050 but not necessarily sufficient. It isimportant that other key factors be addressed toensure that 2050 does not see increasing polarizationof the situation in the world today, with somepopulations suffering record levels of obesity on the

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same planet while others have large numbers of peopledying from lack of food.

Here is a short list of some of these key factors thatmust be addressed to ensure that the world’spopulation can be fed in 2050.

• Food and Income: Even today, in a time ofrelative abundance of food per capita, the UNFood and Agriculture Organization estimatesthat almost one billion people around theworld, one in six people, are significantlyundernourished each year. Food securitydepends not only on overall abundance of foodbut also on people having sufficient income togrow or purchase food.

• Protecting Farmland: The UN estimates thatarable land has the capacity to grow possiblyanother 12 percent in those areas that aren’tforested or erodible. But this growth could becountered by the loss of prime farmland tonon-agricultural uses. Urbanization of farmlandis a major problem. For example, China’surban land area has been increasing by morethan 2 percent annually for the past five years,with legal and illegal conversion of farmland.Additional farmland in China is being lost todesertification and to severe environmentalpollution. In the United States, an area the sizeof Indiana—23 million acres of farmland waslost to development from 1982 to 2007. InOhio, land in farms decreased 100,000 acresfrom 2009 to 2010 and is now at 13.7 millionacres. See American Farmland Trust, Farmingon the Edge Report: What’s Happening toOur Farmland?, available at http://www.farmland.org/resources/fote/default.asp.The United States does have about 32 millionacres of land that was taken out of row cropproduction and placed under long-termeasements in the Conservation ReserveProgram. But much of this land is highlyerodible land not suitable for cultivation. If it isbrought back into production, at the cost oflost conservation values, it will not replace onan acre-for-acre basis the prime farmlandbeing lost to development. In addition, heavy

use of the land for agricultural production couldlikely result in high levels of erosion, with theresult of pollution and degradation of localwater resources.

• Use of Prime Farmland for BiofuelFeedstocks: The last decade has seen anincrease in the use of arable farmland, includingprime farmland, to produce biofuels in theUnited States and other countries. In theUnited States, in 2011, almost 40 percent ofthe corn crop will likely be processed forethanol, which removes a significant portion ofthe energy provided in the corn kernel. Inaddition, the 2008 Farm Bill’s Biomass CropAssistance Program (BCAP) has targetedsubsidies to the removal of crop residues foruse in biomass facilities with little concern forlong-term soil quality and health. TheOrganisation for Economic Development—UN Food and Agriculture Organization’sAgricultural Outlook 2010–2019 predictsthat by 2019 about 13 percent of the globalproduction of coarse grains will be used toproduce ethanol compared to 9 percent overthe base. About 16 percent of the globalproduction of vegetable oil will be used toproduce biodiesel compared to 9 percent overthe base. The share of sugar cane to be usedfor ethanol production at the worldwide level isexpected to reach almost 35 percent in 2019.See Agricultural Outlook—BiofuelProduction 2010–2019, available at http://www.agri-outlook.org/document/9/0,3746,en_36774715_36775671_45438665_1_1_1_1,00.html.As the world’s population grows, the use ofarable land for the production of biofuels willlikely loom large as critical global policy issue.

• Equitable Access to Farmland: In 2008, theworld saw a major spike upward in the priceof food that is attributable to a number ofcauses including diversion of prime farmlandland to crops to be used for biofuel, droughtand other natural disasters, and the worldwideeconomic crisis that affected credit and othereconomic factors. The result was anacceleration of a 21st-century land grab inAfrica for both food and biofuel production by

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European, Middle Eastern, and Indiancompanies. China has also been aggressivelyacquiring farmland in Africa and other countriesaround the world, either by leasing or outrightpurchase. Reports from developmentspecialists in some countries indicate that localfarmers are being pushed off the land and foodis being exported away from hungrypopulations. See, e.g., John Vidal, How Foodand Water Are Driving a 21st-CenturyAfrican Land Grab, THE OBSERVER, Mar. 7,2010, available at http://www.guardian.co.uk/environment/2010/mar/07/food-water-africa-land-grab/print.

• Food and Diets: Over the last decade,increased industrialization and manufacturing inIndia and China fostered the emergence of agrowing middle class with more disposalincome. As a result both countries have seendietary shifts to higher consumption of meatand dairy (a “Western” diet), resulting insignificant loss of food calories worldwide ascereals are diverted to animal feed. The UnitedNations Environmental Programme (UNEP)estimates the loss as the annual calorie need for3.5 billion people (see Right to Food Report at4). The global food system may simply not beable to support the extension of thiswesternized diet to additional billions ofpeople.·

• Curbing Wasted Food: Food waste occursboth in developed and developing countries,with significant waste in developed countriespost-purchase. This wastes food and the waterused for its production and disposal. Forexample, U.S. food waste loss could be ashigh as 50 percent, according to some recentestimates. Up to 25 percent of U.S. freshfruits/vegetables is lost between the field andthe table. Australia estimates that food wastefills half of its landfills. Almost one-third of allfood in the United Kingdom goes to waste. Indeveloping countries, pests and pathogenscause production losses as high as 40 percentof the potential harvest. In Africa, the totalamount of fish lost through discards, post-harvest loss, and spoilage may be around 30

percent of landings. The UNEP reportestimates that 30 million metric tons of fish arediscarded at sea annually. See UNEnvironment Programme, The EnvironmentalFood Crisis: The Environment’s Role inAverting Future Food Crises (2009),available at http://www.grida.no/publications/rr/food-crisis/.

Martha Noble is a senior policy associate for theNational Sustainable Agriculture Coalition inWashington, D.C., and the AgriculturalManagement Committee’s vice chair for the Year inReview. The views in this article are those of theauthor. She can be reached at noble@penn.com.

LIKE TO WRITE?

The Agricultural Management Committeewelcomes the participation of membersinterested in preparing this newsletter.

If you would like to lend a hand by writing,editing, or identifying authors or issues,please contact the editor, Thomas P.Redick at thomasredick@netscape.net.

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REGULATORY DIFFERENCES IN EU/U.S.APPROACHES TO GENETICALLY

MODIFIED CROPS

Stan Benda, Ph.D.

Science uncovers and transmutes discoveries intotechnology. Advanced societies favor and are premisedon technological innovations. True capitalist economiesadhere to a legal system that not only grants civil rightsbut also protects property rights. This means the statemust have reasons for restricting new technologies, notfor introducing them. Yet today we almost have afevered guilt over the idea of progress. In somequarters the argument is that technology must bejustified not just regulated. In some jurisdictions thatargument has crystallized into a regulatory approach.

How can an agricultural regulatory or trade lawyerunderstand the underlying or core concepts ofcompeting regulatory regimes used across the globe?We suggest the starting point is by looking at twomutually exclusive approaches/philosophies thatcapture most regimes: the United States and theEuropean Union (EU).

The U.S. National Academy of Sciences (NAS) in1983 developed its risk assessment framework (RAF)to deal with the regulation of advanced technologyproducts (http://www.nationalacademies.org/). Theobjective was to balance technological progress andtechnological precaution, given the large informationgap between innovators and consumers. To bringscience into public policy development, NASsuggested three prongs: (1) risk assessment: theprovision of objective scientific data on risk; (2) riskmanagement: regulatory decision making consideringthe risk assessment; and (3) risk communication: thetwo-way flow of information not only betweenassessor and managers (regulators) but also betweenmanagers and all stakeholders, e.g., promoters andconsumers. By injecting science into the public policydevelopment, real safety issues are disentangled fromnormative beliefs, also known as values or concerns.

With this RAF, science-generated facts prevail overbelief and supposition. Science helped us forget fears

over “infectious” cancer wards, and cured polio. Yetwe still have anti-vaccination, anti-fluoride, anti-pasteurization movements. Markets form around suchopposition with vague legal definitions (e.g., “organic,”“natural,” and “sustainable” are ubiquitous on foodlabels and imply the food is safe, healthy, and benign).These constituencies demand that their regulatorysystem respect their values, beliefs, and fears no matterhow divorced those ideas are from fact. Indeed, someeven demand the banning of technologies notconsistent with their ideologies.Genetically modified (GM) crops entered this intensequarrel with a combustible mixture of issues: theauthority and role of scientists; conflicts of expert andpublic opinion; the ethics of intervention in nature;globalization; the growth of corporate power; foodproduction and safety; medicine and health; intellectualproperty rights; conduct and influence ofnongovernmental organizations (NGOs); lack of trustin regulators; irreversibility of biotechnology; seedoligopoly; damage to food quality and nutrition;superweeds/superpests; new viruses; and so on.

In North America, the approach is to assess andregulate the GM product consistent with the RAF. TheEU approach changed with genetic modifcation. Underpublic and NGO pressure, the EU drifted into a systemwhere it assesses and regulates the GM process; thenecessary implication is that the safety of the product isneither relevant nor persuasive. Dr. Grant Isaacelegantly organizes this labyrinth of positions withinwhat he calls risk trajectories: the science rationalityand social rationality schools. When thought of asprisms, these schools separate out a spectrum of issuesshining from novel technologies. Two points arefundamental. First, no risk issue can be viewed inisolation; it must be scrutinized within the matrix of therespective schools. Second, the schools are opposites:each element of a school has its antithesis in the other;satisfying the adherents of one school will inflame theadherents of the other. The table attached at the end ofthis article delineates the respective principles/elementsof each school.

Isaac holds that all technology produces two types ofrisks and benefits—technology inherent andtechnology transcendent. The former are directly

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linked to the technology, while the latter areconsequences from its use. In the EU, for example,products made “from” GM crops (like processed soyor canola oils) are labeled, despite the absence ofinherent, detectible proteins.For GM crops the technology-inherent benefits areprecision breeding for market and environmentallydemanded phenotypes (e.g., pest resistance). Thetechnology-inherent risks of genetic modification arethose identified as risks to the environment or people(e.g., superweeds/allergens).The second type of risks and benefits is technologytranscendent, referring to the risks arising from theeconomic-political-social effects of the application,management, and distribution of the technology.Technology-transcendent benefits arise from GMcrops through public and private research that allowsfarmers to become more economically stable, so thatgovernments reap the double benefit of decreasedpublic support of farms and decreased public spendingon research. Technology-transcendent risks include thecosts that GM crops pose to small farms, thepromotion of high-input agriculture, and the plethora ofproxy issues, such as the friction between intellectualproperty rights and farmers’ rights.

Science rationality operates on empirical questions andfacts (evidence based or rules based). Scienceproduces facts that transcend cultural issues, so thatregulatory policies encourage technological progresswhile managing risk.

The social rationality perspective views science andtechnology with suspicion. Science and technologybring change, but change disrupts the prevailing socialfabric or what is called the “normative construct,”including moral, ethical, and religious concerns. Theconcern is particularly with technology-transcendentrisk. The necessary corollary is that regulatory policiesought to ensure technological precaution. If scienceis going to bring change, then it is important to dealwith all impacts of this change in a socially responsivemanner. Science in pursuit of empirical questions is notsensitive to peoples’ values and preferences.

The Luddite story of textile workers attacking mills isoften applied as a critique of the social rationality

school. Technically, Luddites did not oppose progressqua progress, but rather the core ethic of laissez-fairecapitalism. Heretofore the woolen industry hadoperated with a moral view of economic relationshipsthat spoke of paternalism, stability, protectionism, andregulation. Industrialization nullified community andfamily customs, while trade imperatives overrodeprotectionist strictures. Together these forces abolishedwhat had been a highly regulated, hierarchical laborregime. The moral, social, and economic framework ofwoolen industry workers’ society changed to theirdetriment. Luddites were common labor without anyguild-like or seniority protections whatsoever, andhistory shows changes made in response to suchconcerns.

Therefore regulatory oversight should focus on publicconcerns and fears. That means the focus is onspeculative or hypothetical risk rather than the scienceapproach of actual or probable risk. The device thatenables that focus is the precautionary principle.Regulation is about technology assessment notproduct assessment.

For instance, with GM food labeling, the scienceschool labels on the basis of the need to know—compositional changes or threats, such as allergens—which is based on the product. This ensures thatconsumers are aware of actual, objective risks. Thesocial school labels on the basis of the right to knowand that is fixated on the process or productionmethod. This relies on the precautionary principle tomanage risk by catering to the consumers’ perceptionsof risk.

In North America the regulatory burden of proof is thatthe technology is deemed safe if has not been shown tobe unsafe. This is in keeping with the fundamentalscientific reality: science cannot prove a negative.Science can never say something does not cause harm(or is completely safe). Science can only say there isno evidence/experience of harm.

Adherents of the social school take this scientific realityand turn it into a devastating rhetoric device for slantingpublic opinion: A lack of evidence of no harm is notevidence of no harm. Prove it is safe before we eat

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it! The other way this is voiced is by saying we need totest it for generations before it is authorized.

The dichotomy continues into the international arena, intrade and environmental treaties. Contrast the WorldTrade Organization (WTO) with multilateralenvironmental agreements such as the Convention onBiological Diversity and the Cartagena Protocol onBiosafety (www.biodiv.org). The WTO attempts todepoliticize trade and make it a function ofcomparative advantage by insulating trade agreementsfrom socioeconomic assessments. This is the principleof nondiscrimination. A herbicide-tolerant GM wheatcrop that is substantially equivalent to a herbicide-tolerant mutagenic wheat crop that is substantiallyequivalent to a herbicide-tolerant somatic hybridizationwheat crop should all be treated the same, for tradepurposes. Only if there is empirical evidence ofprobable—not possible—harm, can a jurisdiction takesteps that would otherwise be trade noncompliant.

In contrast, the EU is a great advocate of theCartagena Protocol, which deals exclusively with the(GM) process, contains a robust version of theprecautionary principle, and raises issues ofsocioeconomic assessment. The EU takes the stancethat regulation must reflect public attitudes, regardlessof scientific findings. The precautionary principle allowsit to consider public risk tolerance as opposed toscientific risk assessment. Therefore tradeprotectionism for (speculative/values based) foodsafety is both valid and socially acceptable.The social rationality approach encompasses themetaphysical since those too are values and beliefs.

The idea that there is a sacred trust betweenmankind and our Creator, under which weaccept a duty of stewardship for the earth. . . .Even those whose beliefs have not included theexistence of a Creator have, nevertheless,adopted a similar position on moral and ethicalgrounds. It is only recently that this guidingprinciple has become smothered byimpenetrable layers of scientificrationalism.—H.R.H Prince Charles.[Emphasis added]

Here biotechnology per se is a violation of nature. Themere presence of a transgene—even one that is utterlydevoid of any negative effect—is nonetheless totallyunacceptable. Ecclesiastical concepts of impurity,blasphemy, purity, sin, purging (even fire) are legitimatein social rationality regulation. The high-profileadvocates of this approach include Vandana Shiva andMae Wan Ho, who are frequent speakers at U.S.“sustainable agriculture” meetings. See, e.g., Center forAgricultural Policy, http://www.ansp.org/environmental/2010/06/vandana-shiva-earth-democracy/ (cosponsor,Pennsylvania Association for Sustainable Agriculture).

Through the GM controversies, the EU fell into socialrationality regulation: that means its premise oftechnological precaution; speculative risk;transcendental issues; and the lynchpin of the school—the precautionary principle.

Recently a second private members’ bill in the last fewyears was tabled and defeated in the federal Parliamentof Canada. The genesis for the bill included the loss ofexport markets in flax after biotech flax (Triffid)commingled with export-bound flax. This bill attemptedto displace science rationality with social rationality.The bill required a social economic review of GMcrops prior to regulatory approval. Safety was notdeterminative. Instead, the bill sought regulatoryrecognition of overseas importers potential (social/value) regulatory rejection and generally negativeattitudes toward GM crops, and thus whether Canadashould allow GM crops. The University of Guelphhelped the defeat of this latest bill in part by explainingto members of Parliament the scientific need and riskassessment (RAF) of genetic modification.of crops.

Perhaps this entire abstruse architecture of riskassessment schools and novel technologies can bedistilled to two pithy questions: North America asks“why not?” and the EU asks “why?”

Dr. Stan Benda, Ph.D. (Law) is presently inprivate practice in Toronto, Canada, as well asadjunct faculty, York & Ryerson Universities. Hemay be reached at stanbenda@gmail.com.

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SCIENTIFIC RATIONALITY SOCIAL RATIONALITY

BELIEF Technological progress Technological precaution

GENERAL REGULATORY ISSUES

Type of Risk Recognized / Probable Recognized/Hypothetical Speculative

Risk Tolerance Minimum risk Zero risk

Science Evidence-based/Safety, Health Social Construct/Ethics, Values

Underpinning Theory

Scientific Humanistic

Risk Assessment Safety/Health Safety/Health/Quality “other legitimate factors”

Focus Product Process/Production method

SPECIFIC REGULATORY ISSUES

Substantial Equivalence

Accepts Rejects

Risk Management (RM)

RM is for risk reduction/prevention; safety-health basis

RM is for social responsiveness; socio-economic concerns

Precautionary Principle

Science-based (cost benefit) Social-based (absolutist)

Burden of Proof Innocent until proven guilty Guilty until proven innocent

Structure Vertical (existing structures) Horizontal (new structures)

Participation Narrow: Technical experts/Judicial decision making

Wide: Consensus, social dimensions

Labeling Safety- or nutrition-based—need to know

Consumer right to know

Objective of RM Risk reduction/Prevention Socioeconomic concerns  

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