May 2011 - American Bar Association

Vol. 15, No. 2

May 2011

MESSAGE FROM THE CHAIR

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

James H. Andreasen Another successful meeting in Salt Lake City touched lightly on food and agriculture issues, with sessions relating to Gulf of Mexico seafood safety and climate change. In the near future, we will see agriculture— including aquaculture—playing a key role in feeding the world while also controlling unwanted emissions and sequestering carbon.

This case law update and the articles that follow illustrate the challenges of feeding the world—can farmland be preserved when property rights are involved? What is the role of federal power in interstate commerce, and does it trump state law decisions on health and environmental protection?

As planting season approaches, waves of uncertainty over which biotech crop has approval for planting are sweeping the nation, and many growers in California are wondering whether they will have enough water to maintain their fields or orchards. We open with Jillian Hishaw’s update of agricultural environment case law (assisted by editor Tom Redick), including a Sixth Circuit case allowing rBST milk labeling despite an Ohio ban on such commercial speech, a recent CAFO decision out of the Fifth Circuit and several cases challenging biotech crops. Tom Redick offers an update on the world food crisis, followed by Betty Kiplagat’s summary of biosafety liability issues. Turning to California’s water woes, Mia Brown provides a focused look at one of the emerging challenges to agriculture—sustainable uses of water for endangered fish species vs. agricultural uses.

We will be gathering in Indianapolis for the 19th Section Fall Meeting (October 12–15, 2011). It is not too soon to begin planning for this meeting, which is sure to have useful information for the agricultural environmental law attorney. We had student volunteers in Salt Lake, and hope to have more in Indianapolis this fall. If you have ideas for programs or would like to write for our newsletter, please send me or Tom Redick an e-mail and we will find a way for you to contribute. Young lawyers, students, and consultants are encouraged to jump in—experience is not required to make a difference in SEER.

In a point-counterpoint on biotech and organic crops, Vice Chair Martha Noble addresses organic agriculture’s ability to provide food for the world, while Vice Chair Brandon Neuschafer outlines the 1

Upcoming Section Programs—

Agricultural Management Committee Newsletter Vol.15, No. 2, May 2011 Thomas P. Redick, Editor

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

In this issue: Message from the Chair James H. Andreasen ..................................... 1

May 17, 2011 EPA Regulation of Electric Generation: Train Wreck or Clearing the Tracks for the New Energy Economy? Primary Sponsor: Edison Electric Institute Washington, DC

Case Law Update: Biotech Crops, rBST, Farmland Preservation, and the CAFO Rule Jillian Hishaw and Thomas P. Redick ............ 3 State of the World’s Food Supply Thomas P. Redick ......................................... 6 Liability and Redress: The Supplementary Protocol to the Cartagena Protocol on Biosafety Betty Kiplagat ................................................ 8

May 19, 2011 Nano Governance: The Current State of Federal, State, and International Regulation Quick Teleconference

Little Fish, Big Problem: Endangered Fish Impacts Large-Scale Water Deliveries Mia S. Brown ................................................. 11

May 26-27, 2011 15th Institute for Natural Resources Law Teachers Primary Sponsor: Rocky Mountain Mineral Law Foundation Stevenson, WA

The Role of Biotechnology in Sustainable Agriculture Brandon W. Neuschafer ............................... 13 How to Feed the World In 2050? The Need for Organic and Sustainable Farming Systems Martha Noble ............................................... 17

August 4-9, 2011 ABA Annual Meeting Toronto

Regulatory Differences in EU/U.S. Approaches to Genetically Modified Crops Stan Benda, Ph.D. ....................................... 24

October 12-15, 2011 19th Section Fall Meeting Indianapolis

Copyright © 2011. American Bar Association. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher. Send requests to Manager, Copyrights and Licensing, at the ABA, e-mail: [email protected].

February 22-24, 2012 30th Annual Water Law Conference San Diego March 22-24, 2012 41st Annual Conference on Environmental Law Salt Lake City

Any opinions expressed are those of the contributors and shall not be construed to represent the policies of the American Bar Association or the Section of Environment, Energy, and Resources.

2

CASE LAW UPDATE: BIOTECH CROPS, RBST, FARMLAND PRESERVATION, AND THE CAFO RULE

misleading” given FDA’s policy discouraging such claims. Processors appealed the court’s rejection of their First Amendment and Commerce Clause claims. The court of appeals reversed and remanded, finding the evidence actually supported a compositional difference between milk from untreated cows and conventional milk, emphasizing rBST risks including “several types of cancer” and lower quality milk (higher fat, turns sour faster, lower protein, etc.). In particular, the court relied on a study conducted by the Center for Food Safety. Second, the court found Ohio failed to provide sufficient facts to show that claims of “antibiotic free” and “pesticide free” were inherently misleading.

Jillian Hishaw and Thomas P. Redick International Dairy Food Association v. Robert J. Boggs, Ohio Department of Agriculture, Nos. 09-3515/3526 (September 30, 2010) On September 30, 2010, the Sixth Circuit Court of Appeals reversed the lower court’s decision supporting Ohio’s prophylactic ban on “non-rBST” claims on milk products that distinguish rBST-treated and non-rBST treated dairy milk (rBST is a genetically modified hormone that increases milk production in dairy cows by 10 percent)[. FDA approved this veterinary drug in 1993 and issued voluntary labeling guidance in 1994, discouraging display of composition of product (e.g., “rBST free” is not allowed, because the milk contains natural hormone traces), while encouraging truthful “production claims” that refer to the process used leaving no detectible residues in products (e.g., “from cows not treated with rBST”). After years of activist campaigning against it, Starbucks and many dairy processors of the International Dairy Food Association (IDFA) joined the Organic Trade Association (OTA) in no longer selling rBST milk.

After making this initial finding that the non-rBST claims were not inherently misleading, the court of appeals also found that the rule’s prophylactic ban of composition claims such as “rBST free” was more extensive than necessary to serve the state’s interest. The disclosure of additional information in a disclaimer (e.g., “The FDA has determined that no significant difference has been shown between milk derived from rBST-supplemented and non-rBST-supplemented cows”) would be less burdensome than a total prohibition on commercial speech under the First Amendment. In related Commerce Clause analysis, the court of appeals reversed to allow use of that disclaimer (which processors claimed would unduly burden interstate commerce), holding the disclosure requirement valid under the less burdensome reasonableness standard of Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 (1985) (stating a more lenient standard than Central Hudson scrutiny for disclosure requirements vs. prohibitions on speech) rather than intermediate scrutiny under Central Hudson. Lastly, the court of appeals held that Ohio’s rule does not have an extraterritorial effect in projecting the effects of its labeling ban on the dairy processors’ commerce with other states. The decision is posted online at www.ca6.uscourts.gov/ opinions.pdf/10a0322p-06.pdf.

In May 2008, after IDFA and OTA members (processors) placed non-rBST labels on milk products, Ohio restricted the types of labeling claims dairy processors placed on milk products. Under this law, any claims stating “No Hormones,” “Hormone Free,” “rBST Free,” or “No Artificial Hormones” would be “false and misleading advertising.” IDFA and OTA challenged the regulation as an infringement on their First Amendment rights in violation of the dormant Commerce Clause (void-for-vagueness). The lower court granted summary judgment for Ohio on all but one of these claims, applying the four-part test 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, a compositional claim would appear to be “inherently

Building Industry Association v. County of Stanislaus, Court of Appeals of California, 3

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

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

In an effort to update the Stanislaus County farm mitigation plan, in December 2007, the Stanislaus County Board required a 1:1 ratio; for every one acre of farmland converted to non-agricultural use, one acre must be protected in a conservation easement. For 20acre or greater parcels, developers are required to mitigate upon permit approval. In opposition the Building Industry Association of Central California (BIA), challenged the legal validity of the mitigation requirement. The trial court sided with BIA citing the board’s lack of legal authority beyond the county’s police powers. Additionally, the court held the board failed to show a reasonable relationship between industry impact and public protection. Lastly, the mitigation plan violates state law that prohibits local government from placing a condition approval on the issuance of a conservation easement.

Biotech Sugar Beets—Center for Food Safety 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. District Court in San Francisco ruled the U.S. Department of Agriculture (USDA) was in violation of the National Environmental Protection Act (NEPA) in allowing the planting of genetically modified (GM) beets without performing an environmental impact statement (EIS). Despite the ruling prohibiting the commercialization of GM sugar beets, on February 4, 2011, the USDA began approving permits for the spring planting of GM sugar beets due to industry pressures subject to conditions that appeared to respond to the “partial deregulation” suggested by the U.S. Supreme Court in its RR Alfalfa decision (Geertson Seed Farms v. Monsanto, 130 S. Ct. 2743 (2010)). On February 7, 2011, plaintiffs in Grant v. Vilsack filed a complaint seeking to affirm the USDA partial deregulation, while challenging a few elements (e.g., planting distances, etc.) that producers found excessive.

The California Supreme Court reversed the lower court’s decision. First the supreme court stated the lower court improperly gave the county the burden of proving the relationship of industry impact versus protection. The court found the protective purpose valid since agriculture is the top grossing revenue in the county. Given the county’s pristine soil, water and favorable climate, the loss of farmland to residential development would be irreplaceable. The court found that BIA failed to prove that the mitigation requirement had no relationship to land protection. Second, the court ruled the county had police power to mandate land use regulations under the constitution. Third, the county’s language met the statutory description and use of a conservation easement that is fitting under state law. For land transactions of 20 acres or less,[ payment of an in-lieu mitigation fee is acceptable if diligent efforts to obtain a conservation easement failed. However, for 20 acres or more,mitigation regarding a conservation easement is required but subject to alternative means upon board approval. BIA argued that requiring a developer to utilize a conservation easement during the mitigation process creates an involuntary conveyance on the developer’s personal property rights. The court stated that the

On February 7, 2011, the Center for Food Safety filed a new complaint in the U.S. District Court of Northern California, challenging USDA’s injunction violation and NEPA. On February 18, 2011, the U.S. district court denied the motion to amend to add this challenge to USDA’s February 4 decision. Center for Food Safety v. Vilsack, 3:10-cv-04038-JSW (Feb. 18, 2011). This case may be appealed, so stay tuned to this newsletter 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 of Agriculture, to vacate the post-EIS unrestricted approval of Roundup Ready® alfalfa. In the complaint filed in Center for Food Safety v. Vilsack, No. Cv11-1310, available at http://www. centerforfoodsafety.org/wp-content/uploads/2011/03/ 4

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

61093 (Mar. 15, 2011), available at http:// civileats.com/wp-content/uploads/2011/03/NPPCetal-vs.-EPA.08-61093-CV0.wpd.pdf. The Fifth Circuit held that EPA’s effort to extend the CWA beyond entities that actually discharge—and to seek penalties merely for failing to apply for a permit— exceeded EPA’s CWA authority. This is deemed a major 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.

USDA’s decision to grant nationwide approval hinged upon its “limited authority” which restricts its scope to “plant pest” risks. Other pending litigation by CFS against GE eucalyptus trees challenges USDA to use the 2008 Farm Bill (which still has not been fully implemented by USDA) to expand its regulatory oversight to include “other effects” of “noxious weeds” to put herbicide-resistant crops into tighter containment.

Jillian Hishaw is an adjudicator for the USDA Civil Rights Division in Washington, D.C. She can be reached at [email protected]. Thomas P. Redick practices law as Global Environmental Ethics Counsel in St. Louis, Missouri, and is newsletter coordinator for SEER and editor of the Agricultural Management Committee Newsletter (e-mail: [email protected]).

National Pork Producers Council v. EPA, 0861093 (March 15, 2011) In a recent decision of the Fifth Circuit Court of Appeals, EPA’s controversial CAFO rule (published 2008) regulating concentrated animal feeding operations (CAFO) to obtain wastewater discharge permits under the Clean Water Act (CWA) was struck down. This is the second time EPA’s decisions have been successfully challenged. In 2005, the U.S. Court of Appeals for the Second Circuit in New York City vacated key aspects of the first regulation (published 2003) ruling that the CWA requires National Pollutant Discharge Elimination System (NPDES) permits only for actual—not “potential”—discharges of CAFO waste. EPA tried another approach in 2008, and that was 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.

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 to the goal of planting one million trees across the United States in the next five years. In addition to planting trees, the Section also intends, through public outreach and partnering efforts, to raise the nation’s awareness of the multiple benefits of trees. To participate in the One Million Trees Project, please click on the “Projects & Awards” link on our Section Web site:

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

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

5

STATE OF THE WORLD’S FOOD SUPPLY

Agriculture Organization said world food prices have already risen to their highest point since 1990, when the FAO first began tracking prices. The United Nations is expecting high prices in developing nations that depend upon grain imports, with its “food price index” tracking at 32 percent higher from June to December 2008 (William Neuman, U.N. Notes Sharp Rise in World Food Prices, N.Y. TIMES, Jan. 6, 2011, at B1).

Thomas P. Redick In a recent TV interview, French Farm Minister Bruno Le Maire accused high commodity prices of having “disastrous effects on farmers, consumers, and developing countries,” suggesting that steps must be taken to curb volatility. If prices continue to rise in 2011, the world may see a repeat of the 2008 food riots. See Reuters Insider TV, http://bit.ly/eULT8q. Reports range from growers celebrating the good fortune of high prices to animal feeding operations complaining of the same price hike. Amid general concern over the impact on the economy there are inflammatory accusations that policy decisions, including corn-based ethanol, are driving high food prices (see, e.g., AP Newswire, Wholesale Prices Spike on Steep Rise in Food, Oil, ST. PETERSBURG TIMES, Mar. 17, 2011, http://www.tampabay.com/ news/business/personalfinance/wholesale-prices-spikeon-steep-rise-in-food-oil/1157789 (AP Steep Rise)). Bloggers suggested that U.S. policies were to blame in part for historically high milk prices and $7 corn. See, e.g., Jeffrey Folks, Obama’s High Food Price Policy Stealing Milk from Babies (Mar. 29, 2011), http:// www.americanthinker.com/2011/03/ obamas_high_food_price_policy_1.html.

In the United States, leading agricultural economists studying this issue had suggested that trouble would arise from fundamentals in supply and demand for soybeans and corn. Darrell Good, a University of Illinois researcher, reported on the state of production and demand at a “farm profitability” session in Champaign, Illinois, earlier this year. He reported that corn and soybean prices moved higher over the last six months of 2010, getting closer to the high levels seen in 2008. 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 higher than 2008. As of the publication of this article, soybeans were trending at $13 per bushel, and corn droughts in Russia last year and currently in Argentina (e.g., 20 percent less corn) will make supplies of key commodity grains scarcer, and price pressures will increase even with high levels of production in the United States. Australia’s flood could hamper its production, as well as water scarcity there. In short, there is justifiable concern that political instability could lead to more reports of food riots in developing countries. In 2008, over 20 nations reported such unrest—this will be an issue to watch in 2011–2012. See, e.g., VOA, 2 Killed, Hundreds Injured in Algerian Food Riots (Jan. 8, 2011), http:// www.voanews.com/english/news/Two-KilledHundreds-Injured-in-Algerian-Food-Riots113133109.html.

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

While the earthquake in Japan might hold lower oil prices steady for a month or two, and food price increases have slowed as this article was going to press, the future remains uncertain. Japan is already a big oil consumer. As the country begins to rebuild later this year, it will need more energy to rebuild and to make up for power lost due to damaged nuclear

Most economists expect food prices to keep increasing in 2011 and the United Nations Food and 6

facilities, which could push up prices further. The turmoil in the Middle East is a major reason that motorists are facing higher gas prices and it shows no signs 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 and biodiesel, which were extended in 2010. In the EU, the Renewable Energy Directive entered into force and Germany’s aggressive implementation will drive more use of food crops for biofuels. The renewable fuel standard is also driving higher levels of food crops diversion to biofuels, and Congress will need to make some decisions about mandates that can only be met by using food crops. If U.S. ethanol plants are using 50 percent more U.S. corn by 2016, will corn production keep pace? Production reportedly kept pace with demand in 2008, with breeding and agronomy providing 25 percent more corn, at a time when ethanol plants used 25 percent of the supply—but prices still spiked, in part due to speculation in futures markets.

New Edition

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Since 2008, the demand for ethanol feedstock (corn) increased by 17 percent in September–December 2010, when USDA projected 5.1 percent (see Darrell Good, supra). Corn stocks are as low as they have been in 15 years, and depending on the amount of corn produced in 2011 in the United States, these stocks may remain low.

This clearly written, detailed, and timely book covers all aspects of the environmental issues that must be considered in the purchase, sale, or finance of office, retail, manufacturing, or multifamily properties. Its 29 chapters are organized into five parts for quick access to pertinent information: • Basic issues of environmental liability • Environmental due diligence • Environmental matters in the transactional and business context • The most common environmental problems affecting developed properties • Environmental problems that arise in the land development process

As this food price issue evolves, the questions relating to policies will necessarily resurface. This newsletter will continue to report on the evolution of policies relating to such high food prices, so stay tuned. Thomas P. Redick practices law as Global Environmental Ethics Counsel in St. Louis, Missouri, and acts as newsletter coordinator for SEER, in addition to editing the Agricultural Management Committee Newsletter (e-mail: [email protected]).

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LIABILITY AND REDRESS: THE SUPPLEMENTARY PROTOCOL TO THE CARTAGENA PROTOCOL ON BIOSAFETY

there is damage caused by LMOs. The approach operates at the national level and gives the national authority the competence to directly address operators responsible for activities that pose a threat to the environment. The competent authority may request the operator to provide information on imminent threats to the environment in order to take preventive action or remedial action if damage has already occurred. The approach also allows for intervention before damage has occurred. Under the administrative approach, the competent authority may take the necessary measures itself and seek compensation for the costs from the operator.

Betty Kiplagat Introduction The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (Biosafety Protocol) was agreed to by the Fifth series of the Conference of Parties serving as the Meeting of Parties (COP/MOP 5) in Nagoya, Japan, in October 2010. The Supplementary Protocol was developed to address Article 27 of the Cartagena Protocol, which called for the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms. Press Release, Convention on Biological Diversity, “ The Nagoya–Kuala Lumpur Protocol on Liability and Redress for Damage Resulting from Living Modified Organisms born in Nagoya” http://www.cbd.int/doc/ press/2010/pr-2010-10-12-nklp-en.pdf . The Supplementary Protocol is open for signature from March 7, 2011 to March 6, 2012, and shall enter into force on the 90th date after the date of deposit of the 40th instrument of ratification, acceptance, or accession.

Civil Liability During the negotiations, Parties agreed to develop a legally binding SP based on an administrative approach including a provision on civil liability. Civil liability is the liability of an entity for damage sustained by another private entity. Civil liability is governed by internal or national law, and claims are brought before a national court by the private entity that suffered the damage. It had been argued by some Parties that there was a need to develop internationally binding civil procedure in the context of LMOs that would create uniformity as it was noted that courts of different countries have different civil procedure rules. Parties that opposed the formulation of internationally binding civil procedures argued that most of the member states already had in place civil rules and procedures within their jurisdictions, and therefore there was no need to create internationally binding procedures.

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

After protracted negotiations, it was agreed that Article 12 states that parties shall provide for response measures relating to damage to biodiversity by LMOs in their domestic law by either applying existing domestic laws and/or by developing civil liability rules and procedures specifically for this purpose. When developing a domestic civil liability regime, each party will in accordance with their domestic law address issues relating to damage, standard of liability, including strict or fault-based liability, channeling where appropriate, and right to bring claims. (Legal channeling means that liability is exclusively concentrated and allocated to a predefined party.)

Administrative Approach for Addressing Damage from LMOs The Supplementary Protocol (SP) establishes an administrative approach for addressing liability and redress concerns relating to living modified organisms (LMOs). An administrative approach does not necessarily involve adjudication by the courts. All matters are dealt with administratively—usually by a designated national competent authority or regional body delegated to act by several national competent authorities. The aim is to ensure fast and adequate preventive response and remedial measures where 8

Definition of Damage

market, the developer, the producer, the notifier, the exporter, the importer, the carrier, or the supplier. This list is indicative of possible operators that should be determined at the national level, thus Parties can provide a definition that is more or less inclusive in their domestic law when implementing the SP. During the negotiations, there was a clear divide on whether the definition should be narrow, so that only those responsible 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 normal commercial activities could inhibit trade and utilization of crop technology. Conversely, others felt it was essential that damage stemming from all aspects of transboundary movements of LMOs be covered, whether the damage occurs at the transit, handling, or usage stage. It was, however, decided that the definition of operator should include both the person in direct and indirect control of the LMO. This was understood to capture both the person that is in operational control of the LMO when the response measures are required (e.g., the carrier) as well as the person responsible for damage due to the intrinsic properties of the LMO (i.e., the developer or producer).

The definition of “damage” was central in the negotiations. During the negotiations, some Parties preferred a broad and inclusive definition while others preferred a simple definition. The broad definition it was argued would include matters relating to sustainable use of biological diversity, conservation of biological diversity, costs of preventive and response measures, socioeconomic considerations, traditional damage, and human health. (Traditional damage includes death, personal injury including negative impacts on health, and damage to property and economic interests.) Those who preferred a simple definition proposed that the definition of damage should be limited to damage to biological diversity (or damage to the conservation and sustainable use of biological diversity) and damage to human health—but only to the extent that it arises from adverse effects on biological diversity. After protracted negotiations, Parties agreed to a compromise between the two positions and defined damage as an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health. The damage has to be measurable or otherwise observable and significant. The process of determining whether damage has occurred should wherever possible take into account scientifically established baselines that are recognized by a competent authority and should also take into account any human-induced or natural variations. The determination of a “significant” adverse effect will be determined by factors such as long-term or permanent change; the extent of the qualitative or quantitative changes that adversely affect the components of biological diversity; the reduction of the ability of components of biological diversity to provide goods and services; and the extent of any adverse effects on human health in the context of the Supplementary Protocol.

Scope The SP applies to living modified organisms intended for direct use as food or feed, or for processing; destined for contained use (for example, for research in a laboratory); and those intended for intentional introduction into the environment. During the negotiations, it emerged that the Parties had different understandings of the contentious “products thereof” that were not included in the Protocol—e.g., processed materials made from living modified organisms, such as corn oil from genetically engineered corn. While mention of “products thereof” was eventually removed from the operative text of the SP, the report of the meeting recorded an understanding that Parties may apply the SP to damage caused by processed materials that are of living modified organism origin, provided that a causal link is established between the damage and the LMO in question.

Definition of “Operator” The definition of “operator” was also highly contentious because it dealt with the channeling of liability. The SP definition of “operator” is broad and includes the permit holder, the person who placed the LMO on the 9

The compromise to record the understanding in the final report of COP/MOP 5 was important as it allowed for the exclusion of “products thereof” in the scope of the SP. Financial Security The right of Parties to provide for financial security in their domestic laws is enshrined in the SP. Financial security ensures that, if for any reason, the responsible party 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 the right to provide for financial security in their domestic law. Any provision of financial security should be consistent with the Parties’ rights and obligations under international law. The Supplementary Protocol further provides that Parties shall request the Secretariat to undertake a comprehensive study on matters relating to financial security. The Compact In response to Article 27 of the Cartagena Protocol, CropLife International, a group of six leading plant biotechnology companies, including BASF, Bayer CropScience, Dow Agrosciences, DuPont, Monsanto, and Syngenta, presented the Compact as an alternative mechanism to the development of a liability and redress

regime. The Compact is a binding contractual voluntary private sector mechanism that will remedy actual “damage to biological diversity.” The Compact came into effect in 2010 and during the negotiations the parties agreed to note in the report the initiative by the private sector concerning recourse in the event of damage by LMOs. Conclusion The adoption of the Nagoya-Kuala Lumpur Supplementary Protocol marks a milestone for the Parties to the Biosafety Protocol. It establishes an administrative procedure for addressing damage to biological diversity caused by the transboundary movement of an LMO. In preparing to ratify this Supplementary Protocol, Biosafety Protocol Parties should note that domestic law will be central to the implementation of that administrative approach. It is therefore important that Parties undertake a comprehensive review of laws relating to liability and redress within their respective jurisdiction as this will form the basis for implementing the requirements of the SP at the national level. Betty Kiplagat is the legal program/policy officer at NEPAD/African Biosafety Network (e-mail: [email protected]).

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LITTLE FISH, BIG PROBLEM: ENDANGERED FISH IMPACTS LARGESCALE WATER DELIVERIES Mia S. Brown Two-thirds of California’s population and several million acres of farmland rely on surface water that passes through, and is exported from, the San JoaquinSacramento Delta (Delta), which begins in the Sacramento area of northern California, and terminates in the San Francisco Bay. The Delta is the largest estuary system on the West Coast of the United States, consisting of numerous islands surrounded by over 700 miles of waterways, and provides habitat for over 750 species of plants and animals. Some of these species are endangered and measures to protect them have resulted in restrictions on water exports, sparking what on 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 two major water storage and conveyance systems, the Central Valley Project and the State Water Project, both of which divert water through enormous pumping facilities located at the southern end of the Delta. The Central Valley Project (CVP) is operated by the federal government through the U.S. Bureau of Reclamation, and is California’s largest water supplier. It delivers on average over 7 million acre-feet of water per year to irrigate three million acres of farmland in the Central Valley, as well as provides the urban water supply for several surrounding counties. The State Water Project (SWP) is the largest state-built water and power project in the United States. Its system reaches 600 miles from northern to southern California, and provides drinking water for 23 million people and irrigation 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 of a number of endangered plant and animal species that live 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, due to large-scale pumping from the projects. The smelt

was listed as a “threatened species” under the Endangered Species Act (ESA) in 1993, and is now “endangered” and facing extinction. While the smelt has no commercial value as a baitfish or otherwise, it is one of the “indicator species” revealing the Delta’s biological and environmental health. When the projects’ pumps operate, they create a draw so powerful that two rivers within the Delta interior reverse their flow. While fish-screening facilities are used, the collective operation of the projects’ pumps kills Delta smelt and other ESA-listed species (e.g., various salmonids, the Central Valley steelhead, and green sturgeon). In 2005, the U.S. Fish and Wildlife Service (FWS) released a biological opinion (BiOp) regarding the impact of the projects’ operations on Delta smelt and resident salmonid species. The USFWS BiOp concluded that continued operation of the projects would not be detrimental to the continued existence of the Delta smelt. In December 2006 the California Sportfishing Protection Alliance, a nonprofit organization that advocates on behalf of California fisheries, filed suit in federal court challenging the 2005 BiOp and alleged that the SWP’s entrainment of fish was an unlawful “take” (kill) of Delta smelt under the ESA , since the project’s operators lacked the requisite permits from the 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 to analyze significant information and rendering the decision “arbitrary, capricious, and contrary to law.” Judge Wanger directed FWS to revise the BiOp, and in the interim, required reductions in Delta water exports during January through June when the pumping most adversely affected the smelt. As a result, water contractors were told to expect only 35 percent of their 2008 water allocations. FWS released its revised BiOp in 2008, finding that ongoing operations of the projects would jeopardize the Delta smelt and adversely affect its critical habitat. Pursuant to the ESA, the BiOp imposed a “reasonable 11

and prudent alternative” (RPA), which included numerous changes to the projects’ operations that, if implemented, would reduce water deliveries to projects contractors by thousands of acre-feet per year. In response, numerous public water agencies, districts, and other projects water contractors, as well as the state of California (through the Department of Water Resources), sued FWS and the U.S. Bureau of Reclamation, alleging violations of the ESA, the Administrative Procedure Act (APA), and the National Environmental Policy Act (NEPA), collectively called the 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 has also been consolidated regarding the BiOp and matters relating to projects’ operations and their impact on Delta salmonid species (Case No. 1:09-cv-01053OWW-DL, E.D. Cal. June 15, 2009). In 2009, the state entered its third consecutive year of drought, and water contractors were informed that they could expect further reduced water deliveries from the projects. On May 31, 2009, the export pumps were briefly shut off all together (though exports commenced June 1), drawing national attention. Disgruntled water contractors launched a massive public relations campaign decrying the situation as a “Congress-created dustbowl,” and alleging that protection of a commercially valueless minnow would bring California’s billion-dollar agricultural industry to its knees. Fields were fallowed, almond and other orchards were uprooted, creating a dramatic backdrop for roadside signage blasting the federal government for creating modern-day “grapes of wrath” conditions in the Central Valley. Conservative talk show host Sean Hannity (Fox News) did a live broadcast from Fresno County, a Central Valley region that relies heavily on water exported from the Delta, showing the purported “devastation” wrought by reduced water deliveries, including displaced farmworkers at the local food bank, dry and dusty fields, and protesters demanding that President Obama “turn the pumps back on.” The media coverage attributed the plight of the Central Valley to the export reductions imposed by the BiOp and Judge Wanger’s decisions. What received little attention, however, was that export reductions for

2009 were only 25 percent attributable to restrictions and 75 percent due to drought, according to the state’s Department of Water Resources. In reality, 2009 was a relatively normal year for water use, and while Fresno County farm revenues experienced a decline in 2009, it was only by 4.5 percent according to the county’s annual crop report released in June of 2010. Also ignored was the impact that Delta pumping schedules had on salmonid species and the recreational and commercial salmon fishing industries in northern California, which closed for much of the 2008 and 2009 seasons. In December 2010, Judge Wanger issued a 225-page opinion on the 2008 FWS BiOp, placing blame on the “fish vs. farmers” water war waged in 2009. Judge Wanger found that the findings contained in the BiOp and the resultant flow requirements imposed by the RPA were “arbitrary, capricious, and unlawful,” for failing to use the best available science as required by the ESA. While the decision upheld the basic conclusion that export operations adversely affect smelt, it directed FWS to revise the BiOp for failure to, among other things, consider the economic effects on farmers and other businesses reliant on water deliveries and explain how the RPA’s export restrictions protect smelt populations better than less harmful alternatives. FWS must now return to the drawing board to address the deficiencies identified by the court. It is unclear how export operations will be impacted in the interim. On March 9, 2011, FWS announced a public comment period on longfin smelt through April 9, 2011. FWS will review scientific, commercial, and other information on listing of the longfin smelt under the Endangered Species Act (ESA). It expects to issue the determination by September 30, 2011. In a related matter on March 25, 2011, a panel of the U.S. Circuit Court of Appeals voted 3-0 to uphold Judge Wanger in the consolidated smelt cases, holding that federal protection was proper under the ESA and the Commerce Clause, even where a species resides only in California with no commercial value (Steward & Jasper Orchards v. Salazar, 2011 DJDAR 4419). California’s water issues are complex, and will continue to be litigated for the foreseeable future. It can be said 12

THE ROLE OF BIOTECHNOLOGY IN SUSTAINABLE AGRICULTURE

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

Brandon W. Neuschafer Mia Brown practices water, agriculture, and public agency law with the firm of Neumiller & Beardsley in Sacramento, California. She can be reached at [email protected]. Editor’s Note: At the Salt Lake City meeting, Cynthia Koehler of the Environmental Defense Fund 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-conferenceon-environmental-law/Meeting%20Materials/ postprogram/Koehler_wm_ACEL2011.pdf.

The Year in Review 2010 is now available online! Section members are now able to view Environment, Energy, and Resources Law: The Year in Review 2010 in the Section Members Only portion of the Section Web site. The online version contains all chapters found in the printed copy, each in .pdf format. As a Section member, you have access to view The Year in Review 2010, as well as back issues starting from 2008, after logging onto the Web site with your ABA Member ID number and password. http://www.americanbar.org/environ/ publications

For thousands of years, human ingenuity has resulted in better and better seed stock through breeding. We have learned to breed certain desirable traits into seed while at the same time breeding undesirable traits out of seed. In the mid-1990s, however, the entire face of agriculture changed with the introduction of crops using recombinant DNA (biotechnology) to make plants that resist pests and herbicides, or possess other beneficial traits. Such crops and animals are called “genetically modified organisms” (GMOs) by activists and some regulatory agencies in foreign markets, but will be called “biotech crops” for this article. With biotechnology, innovators can transform seed to include traits such as herbicide tolerance or insect or disease resistance, or introduce beneficial traits such as drought tolerance. Biotech crops are most often used for food, feed, or fiber production, but certain traits can be designed for industrial uses, for example, corn with enzyme to enhance ethanol production. Although one traditionally thinks of biotech crops with respect to row crops and vegetables, food sources such as biotech salmon and pigs are also in development stages. Biotech traits are becoming more varied, with traits such as drought tolerance, heat tolerance, and salinity tolerance in the pipeline. Indeed, drought-tolerant biotech maize is expected to reach the market within the next five years (Dupont is marketing traditional drought tolerance traits in corn while the biotech trait awaits USDA approval). See Seed Companies Set for Corn Hybrid War with Drought-Tolerance Traits?, Jan. 25, 2011 (“The duo’s entry into the world market could start decades of fierce competition for rain-challenged growers’ business. Biotech varieties in the pipeline for future release may have an even bigger impact than today’s hybrids.”), available at http://cornandsoybeandigest. com/seed/seed-companies-set-corn-hybrid-wardrought-tolerance-traits (last visited Mar. 26, 2011). Other traits being developed include a modification of photosynthetic cycles to reduce carbon releases and to create a nitrogen fixing trait that would reduce fertilizer 13

inputs (and the concomitant costs and environmental impacts from fertilizer production and use). Biotechnology is not just looking at new traits in major crops, but also more varied and minor crops, including potato, bananas, eggplant, tomato, broccoli, cabbage, cassava, papaya, sweet potato, pulses and groundnuts. According to the nonprofit International Service for the Acquisition of Agri-Biotech Applications, plantings of biotech crops in 2010 increased 35 percent to 365 million acres. More than 15 million farmers in 29 countries representing 59 percent of the world’s population planted biotech crops. Developing countries account for 48 percent of these crops, and are expected to plant more biotech crops that industrialized nations by 2015. More than 90 percent of the total number of farmers (14.4 million) were small-scale farmers, representing some of the poorest people in the world. Despite opposition from many consumer and environmental groups (particularly outside the United States), biotech crops enjoy broad support from governments and growers. China, Brazil, India and many other countries are beginning to embrace biotechnology. According to Pioneer, some Asian countries like Indonesia, Vietnam, and Cambodia are encouraging seed companies to register products there. Even traditional opponents, such as the EU, are beginning to change their course. Recently, the European Commission recognized that GMO crops are at least as safe for consumers and the environment as conventional crops, and that biotechnology could help developing countries meet food pressures. There are many reasons for this shift in attitude, including costs of production, yield, and the lack of any documented adverse health effects after 15 years of experience. But perhaps one of the most significant driving forces is recognition of the benefits that biotechnology can provide to a quickly rising and increasingly hungry population. Conventional agriculture alone does not provide a sustainable model for feeding this population, and biotechnology provides a critical, sustainable tool to help combat increasing food needs.

The global population is expected to increase from 6.8 billion in 2009 to nine billion in 2050. Food demand will increase during the same time frame between 70 percent and 100 percent. The United Nations Food and Agriculture Organization (FAO) predicts more food shortages in 2011. While demand is up, food prices are similarly rising. FAO estimates that over the latter half of 2010, the food price index increased 32 percent. February 2011 saw record food prices. Food production is becoming an increasingly more expensive production, both in direct costs such as fuel and indirect costs through the production and use of products such as fertilizers. And while food demand may double over the next 40 years, clearly the amount of land available for cultivation will not expand by similar factors. By one estimate, the amount of arable land will decrease from 0.62 acres per person in 1999 to 0.37 acres per person in 2050. (In 1966, it was 1.11 acres per person.) The end result is that our production efficiency needs to increase. We have to do more with the land and resources we have, lest we see even larger-scale destruction of forested areas for cropland. This often means selecting the best seed with the best traits for the area, taking into account pest pressures and the need for certain quality traits, as well the best agronomic practices. While biotech crops may not be a perfect fit for every field or end consumer, they are certainly a critical tool in sustainably feeding the world. So how do biotechnology and biotech crops fit into the concept of sustainable agriculture? We need to increase yield, but we must also take into account environmental and social factors in order to be sustainable. Each of these concerns will be explored here independently. First, biotechnology improves yields. For example, insect-resistant crops (known as Bt crops, for Bacillus thuringiensis) deliver average yield increases around 6 percent for corn and 11 percent for cotton. In developing countries, yields are significantly higher. Bt cotton in India has increased yields 50 percent, and Bt corn in the Philippines has increased yields 24 percent. These yield gains can be attributed not only to the Bt seed itself, but also better agronomic practices. The important point is that there are significant yield benefits to be gained in developing 14

countries, and biotechnology will play a crucial role in realizing those gains. In 2010, professor Wayne Parrott of the University of Georgia published a paper regarding yield benefits and sustainability of biotechnology. Among other things, professor Parrott compared crops that were largely biotech by 2007 (corn, cotton, and soybean) against wheat, which was entirely non-GMO. He compared changes of certain sustainability-related factors between 1987 and 2007, including yield increases, decreases in land per bushel or pound, decreases in soil loss per bushel or pound, decreases in energy use per bushel or pound, and decreases in greenhouse gas emissions per bushel or pound. On every indicator, each biotech crop performed significantly better than the non-GMO crop. As professor Parrott concluded, while improvements in conventional agricultural practices alone may help yield, they won’t provide the necessary output on their own. Nor will organic practices provide the yields necessary to feed the expanding population. Organic corn and soybean production in the United States consistently demonstrate yields 20–30 percent lower than conventional methods, and evidence of production outside the United States is consistent with these numbers. Yield is not the end of the story; environmental impacts must also be considered. Importantly, we need to consider net environmental impacts and not focus on any single indicator. The charge often levied against biotech crops is that although they may decrease the use of certain classes of pesticides (for example, decreased insecticide use due to insect resistance), they increase the use of other classes 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 herbicide applied to U.S. crops actually decreased by 2 percent, and organophosphate pesticide use (insecticides) decreased 63 percent. Additionally, one cannot ignore that even if herbicide use increases, such herbicides generally pose significantly fewer human health and environmental concerns than potentially more toxic insecticides.

One significant benefit that biotech crops have brought to agriculture is more environmentally friendly agricultural practices, such as the increased ability to use low- or no-till farming. Such methods provide for better erosion control, decreased fuel and energy consumption, and decreased water usage. By some estimates, the reduced fuel use alone in 2007 resulted in carbon emission reductions equivalent to removing 6.3 million cars from service for an entire year. Less plowing also allows the soil to act as a carbon sink, reducing carbon dioxide emissions. Higher yields and increased efficiency could also result in fewer acres of forestland being cleared for crop or pasture usage, which has significant biodiversity and carbon reduction benefits of its own. Various sustainable agriculture standards are taking on the question of whether biotech crops and organic can coexist, with each seeking to define a sustainable production process. This includes a proposed national standard on sustainable agriculture (ANSI SCS-001) that began as organic and became more “sciencebased” after USDA and various conventional farmers intervened. See Thomas P. Redick, Shawna M. Bligh & James Andreasen, Report on ANSI’s Draft National Standard for Sustainable Agriculture, 14 A.B.A. SEER AGRIC. MGMT. COMM. NEWSLETTER at 16, available at http://apps.americanbar.org/environ/ committees/agricult/newsletter/archiveslist.html. Other standards overseas may favor organic production methods (see, e.g., the European Union’s Global GAP standard) or discriminate in subtle ways against biotech crops. Global GAP is a nongovernmental organization that sets voluntary standards for the certification of agricultural products around the globe. Formerly known as EUREPGAP (for European Good Agricultural Practice), this standard strives for worldwide harmonization of sustainability standards. As such, an existing sustainability standard can seek to be recognized as equivalent, provided it meets the requirements. This standard reflects the European bias against 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 crops and maintaining product integrity.” See CB. 2. 5. 4. at Global GAP (2011), Control Points and Compliance Criteria Integrated Farm Assurance at p. 5, available 15

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 more environmentally friendly alternative to biotechnology and conventional cropping systems, but on a large scale, the sustainability of organic methods is questionable. Not only do organic crops suffer from yield drops (meaning the land used for production is less efficient), but nutrient inputs in terms of fertilizer could be costly. We would need substantially increased sources of nutrients (generally manure), and there are significant environmental costs associated with the production and transportation of those nutrients. Biotechnology also provides social benefits, an important consideration for sustainability. As indicated, nearly half of all biotech crops planted in 2010 were in developing countries. In the first 11 years of their use, the incomes of over 10 million farmers who adopted biotech crops increased by a total of between $34 and 46 billion. In developing countries, average household incomes of farmers increased up to 33 percent. In Argentina, it is estimated that the introduction of biotech crops and subsequent no-till methods allowed for the creation of 200,000 jobs, primarily focused on providing new and improved equipment and sources of agricultural inputs. These reductions in fuel use, water use, and chemical inputs, coupled with increased yield potential, mean higher profits and improved quality of life. Additionally, biotechnology and improved cropping practices allow for the mitigation of certain environmental stressors, which could result in more yearly plantings in a rotational system. More plantings generally mean more profits and higher and more consistent employment.

The foregoing is not by any means intended to be an exhaustive discussion of all of the factors demonstrating the sustainability of and need for biotechnology to face our agricultural hurdles. Nor is it to suggest that biotechnology is the answer to all of our problems, or that we should in any way abandon rigorous, sciencebased regulation of biotech crops. Biotechnology is a tool that, along with improved agricultural practices, we must maintain in our arsenal to combat hunger and malnutrition. It should not and does not need to displace organic production, but organic production (which in the United States represents 0.57 percent of farmland, according to USDA) cannot be the driver of global food and agricultural policies to the exclusion of biotechnology. Brandon W. Neuschafer is a partner with Bryan Cave LLP in St. Louis, Missouri. He can be reached at [email protected].

www.ababooks.org Your Source for Books from the Section of Environment, Energy, and Resources and ABA Publishing

But the benefits are not solely economic. For example, Bt corn reduces the formation of carcinogenic mycotoxins, an unforeseen benefit. Moreover, researchers are also looking at traits to improve nutrition levels in food. A classic example is “golden rice,” which has high levels of vitamin A to combat vitamin A deficiency, which afflicts over 120 million people and causes up to two million deaths per year.

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HOW TO FEED THE WORLD IN 2050? THE NEED FOR ORGANIC AND SUSTAINABLE FARMING SYSTEMS Martha Noble According to the U.S. Census Bureau, the world’s population increased in just 80 years from 3.2 billion in 1930 to the current level of 6.9 billion, an increase of 3.7 billion people. By 2050 the world population is projected to increase by 2.4 billion to a total of 9.3 billion people. U.S. Census Bureau, International Database, available at http://www.census.gov/ipc/ www/idb/worldpoptotal.php. This burgeoning population will increase the demands on world resources that are already under heavy stress, including freshwater and arable land, in order to provide sufficient food production to achieve food security. There are two commonly used definitions of food security. The United Nations (UN) Food and Agriculture Organization (FAO) defines food security at a national or global level as including the following set of conditions: food security exists when all people, at all times, have physical, social and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life. See UN FAO, Food Security Statistics, available at http:// www.fao.org/economic/esess-fs/en/. The U.S. Department of Agriculture (USDA) defines food security for a household as “. . . access by all members at all times to enough food for an active, healthy life. Food security includes at a minimum (1) the ready availability of nutritionally adequate and safe foods, and (2) an assured ability to acquire acceptable foods in socially acceptable ways (that is, without resorting to emergency food supplies, scavenging, stealing, or other coping strategies).” See USDA Economic Research Service, Food Security in the United States: Measuring Household Food Security, available at http://www.ers.usda.gov/ Briefing/FoodSecurity/measurement.htm#what. Both of these definitions include basic, adequate nutrition and food safety, with the UN definition also including food preferences.

A third more comprehensive definition of “community food security,” developed by Mike Hamm and Anne Bellows, is used by the Community Food Security Coalition: “Community food security is a condition in which all community residents obtain a safe, culturally acceptable, nutritionally adequate diet through a sustainable food system that maximizes community self-reliance and social justice.” See Community Food Security Coalition, What Is Community Food Security?, available at http:// www.foodsecurity.org/views_cfs_faq.html. The definition and an accompanying set of principles for the definition include attention to the methods by which the food is produced and the importance of maximizing the production of local foods as part of food security. This point-counterpoint essay addresses the question of whether organic and sustainable farming systems can meet the food security needs of the global population predicted for 2050. For purposes of the essay, all three definitions of food security are relevant, including the community definition that emphasizes the importance of farming and food systems that are sustainable over the long term and include attention to the economic and social welfare of communities. The U.S. National Organic Program regulations define “organic production” as “a production system that is managed in accordance with the [National Organic] Act and regulations in this part to respond to site-specific conditions by integrating cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity.” 7 C.F.R. § 205.2. As described by the USDA’s Sustainable Agriculture Research and Education (SARE) program, organic farming entails: • “Use of cover crops, green manures, animal manures and crop rotations to fertilize the soil, maximize biological activity and maintain longterm soil health. • Use of biological control, crop rotations and other techniques to manage weeds, insects and diseases.

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• •

•

•

An emphasis on biodiversity of the agricultural system and the surrounding environment. Using rotational grazing and mixed forage pastures for livestock operations and alternative health care for animal wellbeing Reduction of external and off-farm inputs and elimination of synthetic pesticides and fertilizers and other materials, such as hormones and antibiotics. A focus on renewable resources, soil and water conservation, and management practices that restore, maintain and enhance ecological balance.”

The global organic community, embodied in the International Federation of Organic Movements has adopted four principles to guide the development of organic agriculture. These principles extend beyond the organic farming system to also include critical community and social values, including: •

•

USDA Sustainable Agriculture Research and Education (SARE), Transitioning to Organic Production at 2 (2006), available at http:// www.sare.org/Learning-Center/Bulletins/NationalSARE-Bulletins/Transitioning-to-Organic-Production). Congress recognized the benefits of organic farming systems in the 2008 Farm Bill with numerous provisions to promote organic production. Key provisions were included in the Farm Bill’s conservation programs to provide organic farmers with resources to establish many sustainable practices and systems that can increase the positive environmental performance of organic farms. One measure is an organic initiative in the Environmental Quality Incentives Program (EQIP) that provides cost-share assistance and technical assistance to farmers who want to transition into organic farming or organic farmers who want to bring more land into organic production or add organically raised animals to their farming system. 16 U.S.C. § 3839aa-2(i). In addition, in the Conservation Stewardship Program (CSP) the USDA secretary is directed to develop an organic “crosswalk” that will facilitate the use of the CSP for farmers transitioning to organic farming systems. 16 U.S. C. § 3839f(h). The USDA secretary is also directed to ensure that outreach and technical assistance are available and CSP program specifications are appropriate to enable specialty crop and organic producers to participate in the program. 16 U.S.C. § 3839g(c).

•

•

Principle of Health: organic agriculture should sustain and enhance the health of soil, plant, animal, human and planet as one and indivisible. Principle of Ecology: organic agriculture should be based on living ecological systems and cycles, work with them, emulate them and help sustain them. Principle of Fairness: organic agriculture should build on relationships that ensure fairness with regard to the common environment and life opportunities. Principle of Care: organic agriculture should be managed in a precautionary and responsible manner to protect the health and well-being of current and future generations and the environment

International Federation of Organic Agriculture Movements, Principles of Organic Agriculture, available at http://www.ifoam.org/about_ifoam/ principles/index.html. Organic farming systems are essentially agroecological systems that focus on improving soil health, maximizing on-farm inputs, and farming system diversification. This is in contrast to an industrial based model of farming that relies heavily on purchased inputs and relatively simplified farming systems, for example the current continuous corn production that is found on millions of acres of farmland in the United States. Organic agriculture is also an evolving system that incorporates agricultural production advances that consistently yield benefits, including among others new varieties of crops, precision agricultural techniques, more efficient machinery, and the use of new low-tillage methods of weed control. But not all agricultural methods are used. The standards for organic production are also under constant scrutiny to minimize the use of inputs that have 18

been shown to have significant negative impacts on society and the environment. Importantly, pesticides that result in environmental pollution or rapid pest resistance are avoided. Weed management is controlled by methods that also increase soil carbon and enhance soil fertility, including organic crop rotations, cover crops, and natural-based products. Organic farmers do not use synthetic nitrogen fertilizer, relying instead on composted animal manures, the incorporation of green plant manures, and the use of nitrogen-fixing legumes in crop rotations. They also use biological, cultural, and physical methods to limit pest expansion and increase populations of beneficial insects on their farm. See Iowa State University Extension, Fundamentals of Organic Agriculture (2003), available at http://www.extension.iastate.edu/ Publications/PM1880.pdf.

Nandula-GRW12.pdf. The response of the GMO seed industry has been to incorporate into crop seeds genetic traits for resistance to more toxic herbicides, with more expensive seeds now double or triple stacked with herbicide-resistant traits. In some regions that method is failing, with weeds emerging that are resistant to numerous pesticides. The result is that some weed management specialists are recommending the use of more toxic herbicides and the use of deeper tillage to control weeds. For an overview of pesticideresistant weed species on a state basis, see the North American Herbicide Resistant Weed Survey, available at http://www.weedscience.org/usa/statemap.htm. The overall result is a return to more toxic pesticides combined with higher tillage, with farmers paying more for seeds.

From the perspective of organic farmers, genetically modified organisms (GMOs) constitute synthetic inputs that pose unknown risks or identified risks that make their use counter-productive in the long run. For example, the majority of GMOs currently in use are herbicide-resistant crops that are linked to the use of herbicides. A prime example is glyphosate-resistant crops. In the first few years of their use, glyphosateresistant crops in combination with low-till farming systems did decrease the use of more toxic pesticides and the use of tillage in conventional farming systems to control weeds. But from the beginning, glyphosateresistant crops posed a problem in farming systems with crop rotations. For example, a farmer planting glyphosate-resistant corn in one season could find glyphosate-resistant corn plants popping as recruits in a field of soybeans or cotton in the next season.

Insect-resistant GMO crops are also avoided by organic farmers, in part because they are engineered to contain pesticides that remain in the environment. This can increase the probability of target insects developing resistance to pesticide. In addition, nontarget insect populations can also be affected, including beneficial insects. The most common GMO system for insect resistance is the incorporation of a genetic trait from a bacterium, Bacillus thuringiensis (Bt), which induces the plant to produce a toxin that kills a wide array of insect pests. Ironically, organic farmers have long combined integrated pest management techniques such as scouting for the presence of insect pests, with judicious use of topical application of Bt toxin. With judicious use, Bt pest resistance to the toxin is less likely to develop. See, e.g., Colorado State University Extension, Bacillus thuringiensis, available at http:// www.ext.colostate.edu/pubs/insect/05556.html.

A more serious problem is that as the acreage of gylphosate-resistant crops increased, so did the use of the glyphosate pesticide, including the widespread use of aerial spraying of glyphosate. Not surprisingly a landscape awash with glyphosate is a strong selective pressure on individual plants of weed species that had resistance to glyphosate. See, e.g., Vijay K. Nandula et al., Glyphosate Resistant Weeds: Current Status and Future Outlook, OUTLOOKS ON PEST MGMT., Aug. 2005, available at http://www.ars.usda.gov/ SP2UserFiles/Place/64022000/Publications/Reddy/

In recent years, organic farmers and organizations that represent their interests have launched legal challenges to USDA’s approval of commercial release of GMO crops on the grounds that the agency has failed to undertake a sufficient analysis under the National Environmental Policy Act of potential environmental problems arising from the widespread use of GMO crops, including the social and economic harms arising out of the environmental concerns. See, e.g., Center for Food Safety v. Vilsack (U.S. District Court for the Northern District of California, Case No. CV 11 19

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

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

On March 29, 2011, the Public Patent Foundation filed a lawsuit that challenges the validity of all the patents granted to Monsanto’s transgenic seeds on grounds that patents fail to satisfy requirements of the U.S. Constitution and the Patent Act. The plaintiffs in the lawsuit are also seeking protection from being sued for patent infringement if Monsanto’s transgenic seed is found to have contaminated their land or crops. The plaintiffs include sixty organic and sustainable trade associations and individual plaintiffs who are organic farmers or ranchers. See Organic Seed Growers and Trade Association v. Monsanto Company and Monsanto Technology LLC (complaint filed in U.S. District Court, Southern District of New York, Case No. 11 CIV 2163), available at http:// www.pubpat.org/assets/files/seed/OSGATA-vMonsanto-Complaint.pdf.

In addition, the production of this corn, which is directed to an industrial use, may significantly decrease acreage for food production, including the production of crops other than corn necessary for an adequate and nutritious diet. As Margaret Mellon, director of the Union of Concerned Scientists Food and Environment Program stated, “The USDA has placed the interests of the biotechnology industry over the interests of food processors and the general public. The agency’s priorities are upside down. Food is far more important than ethanol. USDA needs to stop throwing the food industry under the biotechnology bus” (available at http://www.ucsusa.org/news/press_release/usdaderegulates-ethanol-corn-501.html?print=t). With this perspective on organic and sustainable agriculture background, the question is whether these farming systems—based on agroecological models of reducing manufactured inputs, increased diversity of farming systems to help provide and retain nutrients, break up pest cycles, and increase soil structure and health—can feed the world in 2050.

The most recent USDA approval of a genetically engineered crop has generated resistance not only from the organic community but also from food processors. In February, USDA’s Animal Plant and Health Inspection Service approved for commercial use a GMO corn bioengineered by Syngenta with an amylase enzyme that digests starch in the corn to sugars. The corn, dubbed Enogen corn, can be used only by the corn ethanol industry, an industry that benefits from significant Farm Bill subsidies and a federal tax credit enabling more use of ethanol blended with gasoline. A small amount of the amylase containing corn mixed into other corn can render that corn unfit for feed or food uses. USDA released the Enogen corn for commercial use with no required safeguards to ensure that it would not intermingle with corn destined for other uses. Among others, the North American Millers Association objected to the commercial release of Enogen® corn, without sufficient regulatory safeguards to prevent it from intermingling with other corn destined for food and feed uses. Syngenta acknowledged that the food processing industry will be required to test its supply of corn for food uses, forcing

An important point in addressing this question is that of where the largest percent increases in population are expected by 2050. The estimate provided by the Population Reference Bureau is that Africa and other less developed countries will have the largest percent increases, followed by India and China, which retain their position as the two countries with the highest populations. The top 10 nations predicted to have the largest percent increase are all in Africa. In March 2011, the United Nations Human Rights Council released the Right to Food Report, which concluded that agroecological systems of agriculture have proven results for fast progress in achieving food security for many vulnerable groups in various countries and environments. UN Human Rights Council, REPORT SUBMITTED BY THE SPECIAL RAPPORTEUR ON THE RIGHT TO FOOD, (Dec. 20, 2010), available at http://www.srfood.org/images/ 20

stories/pdf/officialreports/20110308_a-hrc-1649_agroecology_en.pdf. An earlier 2007 report by the UN senior officer for Environment and Development concluded more specifically that modern, innovative organic agriculture could play a significant role in feeding the world in 2050. See Nadia El-Haage Scialabba, Organic Agriculture and Food Security in Africa (June 2007), in Aksel Naerstad, Africa Can Feed 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 an extensive literature review in the last five years. A full summary of this report cannot be covered within the limits of this brief newsletter essay, but the gist of the report includes the following highlights drawn from the news release issued with the report: •

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Agroecology can enable small-scale farmers to double food production using ecological methods, within 10 years in regions with critical food needs; Agroecology is science based, drawing on the ecological sciences to design agricultural systems, and the methods of agroecology can outperform the use of chemical fertilizers in boosting food production where populations facing the most hunger live, especially in environments that are less favorable to agricultural production; Agroecological projects in have shown an average crop yield increase of 80 percent in 57 developing countries with an average increase of 116 percent for all African projects; One example of the application of agroecological farming systems is Malawi. The country initially launched a massive chemical fertilizer program a few years ago but then turned to agroecological systems that saw maize yields increase from one ton per hectare to two to three tons per hectare.

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

stories/pdf/press_releases/20110308_agroecologyreport-pr_en.pdf. The report also found that in addition to helping rehabilitate degraded land and increase overall yields, agroecological systems can help alleviate rural poverty. The use of on-farm fertility enhancements can reduce farmers’ reliance on external inputs and on government subsidies. For example in Africa, the planting of trees that fix nitrogen have helped farmers increase soil fertility while providing forage for livestock. Tree species that shed their leaves during the growing season for field crops do not compete for light or moisture during the growing season. The report also emphasized that the increased diversity of farming systems also provided more rural employment and income. This is critically important in India, China, and the developing countries in Africa, where migrants from rural areas are overwhelming the ability of these countries to provide water, adequate facilities for handling human and industrial wastes, and other services required in highly crowded cities. The report concludes with a number of recommendations for other measures that can foster agroecological farming systems, including increasing extension services for farmers in developing countries, reorienting public spending for publicly available goods including an increase of public seed breeding programs for a wide diversity of crops, with the seeds publicly available and with farmers retaining the right of seed saving. Measures will also be needed to increase research that includes farmer participation, increased access to credit, and an increased emphasis on the delivery of credit and assistance to women. The report joins a growing body of research and information about the ability of agroecological sustainable and organic systems to provide sufficient food to meet the needs of the 9.3 billion people expected to populate the world in 2050. The use of these systems will be necessary to achieve food security in 2050 but not necessarily sufficient. It is important that other key factors be addressed to ensure that 2050 does not see increasing polarization of the situation in the world today, with some populations suffering record levels of obesity on the 21

same planet while others have large numbers of people dying from lack of food. Here is a short list of some of these key factors that must be addressed to ensure that the world’s population can be fed in 2050. •

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Food and Income: Even today, in a time of relative abundance of food per capita, the UN Food and Agriculture Organization estimates that almost one billion people around the world, one in six people, are significantly undernourished each year. Food security depends not only on overall abundance of food but also on people having sufficient income to grow or purchase food. Protecting Farmland: The UN estimates that arable land has the capacity to grow possibly another 12 percent in those areas that aren’t forested or erodible. But this growth could be countered by the loss of prime farmland to non-agricultural uses. Urbanization of farmland is a major problem. For example, China’s urban land area has been increasing by more than 2 percent annually for the past five years, with legal and illegal conversion of farmland. Additional farmland in China is being lost to desertification and to severe environmental pollution. In the United States, an area the size of Indiana—23 million acres of farmland was lost to development from 1982 to 2007. In Ohio, land in farms decreased 100,000 acres from 2009 to 2010 and is now at 13.7 million acres. See American Farmland Trust, Farming on the Edge Report: What’s Happening to Our Farmland?, available at http:// www.farmland.org/resources/fote/default.asp. The United States does have about 32 million acres of land that was taken out of row crop production and placed under long-term easements in the Conservation Reserve Program. But much of this land is highly erodible land not suitable for cultivation. If it is brought back into production, at the cost of lost conservation values, it will not replace on an acre-for-acre basis the prime farmland being lost to development. In addition, heavy

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use of the land for agricultural production could likely result in high levels of erosion, with the result of pollution and degradation of local water resources. Use of Prime Farmland for Biofuel Feedstocks: The last decade has seen an increase in the use of arable farmland, including prime farmland, to produce biofuels in the United States and other countries. In the United States, in 2011, almost 40 percent of the corn crop will likely be processed for ethanol, which removes a significant portion of the energy provided in the corn kernel. In addition, the 2008 Farm Bill’s Biomass Crop Assistance Program (BCAP) has targeted subsidies to the removal of crop residues for use in biomass facilities with little concern for long-term soil quality and health. The Organisation for Economic Development— UN Food and Agriculture Organization’s Agricultural Outlook 2010–2019 predicts that by 2019 about 13 percent of the global production of coarse grains will be used to produce ethanol compared to 9 percent over the base. About 16 percent of the global production of vegetable oil will be used to produce biodiesel compared to 9 percent over the base. The share of sugar cane to be used for ethanol production at the worldwide level is expected to reach almost 35 percent in 2019. See Agricultural Outlook—Biofuel Production 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 of arable land for the production of biofuels will likely loom large as critical global policy issue. Equitable Access to Farmland: In 2008, the world saw a major spike upward in the price of food that is attributable to a number of causes including diversion of prime farmland land to crops to be used for biofuel, drought and other natural disasters, and the worldwide economic crisis that affected credit and other economic factors. The result was an acceleration of a 21st-century land grab in Africa for both food and biofuel production by

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European, Middle Eastern, and Indian companies. China has also been aggressively acquiring farmland in Africa and other countries around the world, either by leasing or outright purchase. Reports from development specialists in some countries indicate that local farmers are being pushed off the land and food is being exported away from hungry populations. See, e.g., John Vidal, How Food and Water Are Driving a 21st-Century African Land Grab, THE OBSERVER, Mar. 7, 2010, available at http://www.guardian.co.uk/ environment/2010/mar/07/food-water-africaland-grab/print. Food and Diets: Over the last decade, increased industrialization and manufacturing in India and China fostered the emergence of a growing middle class with more disposal income. As a result both countries have seen dietary shifts to higher consumption of meat and dairy (a “Western” diet), resulting in significant loss of food calories worldwide as cereals are diverted to animal feed. The United Nations Environmental Programme (UNEP) estimates the loss as the annual calorie need for 3.5 billion people (see Right to Food Report at 4). The global food system may simply not be able to support the extension of this westernized diet to additional billions of people.· Curbing Wasted Food: Food waste occurs both in developed and developing countries, with significant waste in developed countries post-purchase. This wastes food and the water used for its production and disposal. For example, U.S. food waste loss could be as high as 50 percent, according to some recent estimates. Up to 25 percent of U.S. fresh fruits/vegetables is lost between the field and the table. Australia estimates that food waste fills half of its landfills. Almost one-third of all food in the United Kingdom goes to waste. In developing countries, pests and pathogens cause production losses as high as 40 percent of the potential harvest. In Africa, the total amount of fish lost through discards, postharvest loss, and spoilage may be around 30

percent of landings. The UNEP report estimates that 30 million metric tons of fish are discarded at sea annually. See UN Environment Programme, The Environmental Food Crisis: The Environment’s Role in Averting Future Food Crises (2009), available at http://www.grida.no/publications/ rr/food-crisis/. Martha Noble is a senior policy associate for the National Sustainable Agriculture Coalition in Washington, D.C., and the Agricultural Management Committee’s vice chair for the Year in Review. The views in this article are those of the author. She can be reached at [email protected].

LIKE TO WRITE? The Agricultural Management Committee welcomes the participation of members interested 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 [email protected].

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REGULATORY DIFFERENCES IN EU/U.S. APPROACHES TO GENETICALLY MODIFIED CROPS Stan Benda, Ph.D. Science uncovers and transmutes discoveries into technology. Advanced societies favor and are premised on technological innovations. True capitalist economies adhere to a legal system that not only grants civil rights but also protects property rights. This means the state must have reasons for restricting new technologies, not for introducing them. Yet today we almost have a fevered guilt over the idea of progress. In some quarters the argument is that technology must be justified not just regulated. In some jurisdictions that argument has crystallized into a regulatory approach. How can an agricultural regulatory or trade lawyer understand the underlying or core concepts of competing regulatory regimes used across the globe? We suggest the starting point is by looking at two mutually exclusive approaches/philosophies that capture most regimes: the United States and the European Union (EU). The U.S. National Academy of Sciences (NAS) in 1983 developed its risk assessment framework (RAF) to deal with the regulation of advanced technology products (http://www.nationalacademies.org/). The objective was to balance technological progress and technological precaution, given the large information gap between innovators and consumers. To bring science into public policy development, NAS suggested three prongs: (1) risk assessment: the provision of objective scientific data on risk; (2) risk management: regulatory decision making considering the risk assessment; and (3) risk communication: the two-way flow of information not only between assessor and managers (regulators) but also between managers and all stakeholders, e.g., promoters and consumers. By injecting science into the public policy development, real safety issues are disentangled from normative beliefs, also known as values or concerns. With this RAF, science-generated facts prevail over belief and supposition. Science helped us forget fears

over “infectious” cancer wards, and cured polio. Yet we still have anti-vaccination, anti-fluoride, antipasteurization movements. Markets form around such opposition with vague legal definitions (e.g., “organic,” “natural,” and “sustainable” are ubiquitous on food labels and imply the food is safe, healthy, and benign). These constituencies demand that their regulatory system respect their values, beliefs, and fears no matter how divorced those ideas are from fact. Indeed, some even demand the banning of technologies not consistent with their ideologies. Genetically modified (GM) crops entered this intense quarrel with a combustible mixture of issues: the authority and role of scientists; conflicts of expert and public opinion; the ethics of intervention in nature; globalization; the growth of corporate power; food production and safety; medicine and health; intellectual property rights; conduct and influence of nongovernmental organizations (NGOs); lack of trust in regulators; irreversibility of biotechnology; seed oligopoly; damage to food quality and nutrition; superweeds/superpests; new viruses; and so on. In North America, the approach is to assess and regulate the GM product consistent with the RAF. The EU approach changed with genetic modifcation. Under public and NGO pressure, the EU drifted into a system where it assesses and regulates the GM process; the necessary implication is that the safety of the product is neither relevant nor persuasive. Dr. Grant Isaac elegantly organizes this labyrinth of positions within what he calls risk trajectories: the science rationality and social rationality schools. When thought of as prisms, these schools separate out a spectrum of issues shining from novel technologies. Two points are fundamental. First, no risk issue can be viewed in isolation; it must be scrutinized within the matrix of the respective 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 the adherents of the other. The table attached at the end of this article delineates the respective principles/elements of each school. Isaac holds that all technology produces two types of risks and benefits—technology inherent and technology transcendent. The former are directly 24

linked to the technology, while the latter are consequences from its use. In the EU, for example, products made “from” GM crops (like processed soy or canola oils) are labeled, despite the absence of inherent, detectible proteins. For GM crops the technology-inherent benefits are precision breeding for market and environmentally demanded phenotypes (e.g., pest resistance). The technology-inherent risks of genetic modification are those identified as risks to the environment or people (e.g., superweeds/allergens). The second type of risks and benefits is technology transcendent, referring to the risks arising from the economic-political-social effects of the application, management, and distribution of the technology. Technology-transcendent benefits arise from GM crops through public and private research that allows farmers to become more economically stable, so that governments reap the double benefit of decreased public support of farms and decreased public spending on research. Technology-transcendent risks include the costs that GM crops pose to small farms, the promotion of high-input agriculture, and the plethora of proxy issues, such as the friction between intellectual property rights and farmers’ rights. Science rationality operates on empirical questions and facts (evidence based or rules based). Science produces facts that transcend cultural issues, so that regulatory policies encourage technological progress while managing risk. The social rationality perspective views science and technology with suspicion. Science and technology bring change, but change disrupts the prevailing social fabric or what is called the “normative construct,” including moral, ethical, and religious concerns. The concern is particularly with technology-transcendent risk. The necessary corollary is that regulatory policies ought to ensure technological precaution. If science is going to bring change, then it is important to deal with all impacts of this change in a socially responsive manner. Science in pursuit of empirical questions is not sensitive to peoples’ values and preferences. The Luddite story of textile workers attacking mills is often applied as a critique of the social rationality

school. Technically, Luddites did not oppose progress qua progress, but rather the core ethic of laissez-faire capitalism. Heretofore the woolen industry had operated with a moral view of economic relationships that spoke of paternalism, stability, protectionism, and regulation. Industrialization nullified community and family customs, while trade imperatives overrode protectionist strictures. Together these forces abolished what had been a highly regulated, hierarchical labor regime. The moral, social, and economic framework of woolen industry workers’ society changed to their detriment. Luddites were common labor without any guild-like or seniority protections whatsoever, and history shows changes made in response to such concerns. Therefore regulatory oversight should focus on public concerns and fears. That means the focus is on speculative or hypothetical risk rather than the science approach of actual or probable risk. The device that enables that focus is the precautionary principle. Regulation is about technology assessment not product assessment. For instance, with GM food labeling, the science school labels on the basis of the need to know— compositional changes or threats, such as allergens— which is based on the product. This ensures that consumers are aware of actual, objective risks. The social school labels on the basis of the right to know and that is fixated on the process or production method. This relies on the precautionary principle to manage risk by catering to the consumers’ perceptions of risk. In North America the regulatory burden of proof is that the technology is deemed safe if has not been shown to be unsafe. This is in keeping with the fundamental scientific reality: science cannot prove a negative. Science can never say something does not cause harm (or is completely safe). Science can only say there is no evidence/experience of harm. Adherents of the social school take this scientific reality and turn it into a devastating rhetoric device for slanting public opinion: A lack of evidence of no harm is not evidence of no harm. Prove it is safe before we eat 25

it! The other way this is voiced is by saying we need to test it for generations before it is authorized. The dichotomy continues into the international arena, in trade and environmental treaties. Contrast the World Trade Organization (WTO) with multilateral environmental agreements such as the Convention on Biological Diversity and the Cartagena Protocol on Biosafety (www.biodiv.org). The WTO attempts to depoliticize trade and make it a function of comparative advantage by insulating trade agreements from socioeconomic assessments. This is the principle of nondiscrimination. A herbicide-tolerant GM wheat crop that is substantially equivalent to a herbicidetolerant mutagenic wheat crop that is substantially equivalent to a herbicide-tolerant somatic hybridization wheat crop should all be treated the same, for trade purposes. Only if there is empirical evidence of probable—not possible—harm, can a jurisdiction take steps that would otherwise be trade noncompliant. In contrast, the EU is a great advocate of the Cartagena Protocol, which deals exclusively with the (GM) process, contains a robust version of the precautionary principle, and raises issues of socioeconomic assessment. The EU takes the stance that regulation must reflect public attitudes, regardless of scientific findings. The precautionary principle allows it to consider public risk tolerance as opposed to scientific risk assessment. Therefore trade protectionism for (speculative/values based) food safety is both valid and socially acceptable. The social rationality approach encompasses the metaphysical since those too are values and beliefs. The idea that there is a sacred trust between mankind and our Creator, under which we accept a duty of stewardship for the earth. . . . Even those whose beliefs have not included the existence of a Creator have, nevertheless, adopted a similar position on moral and ethical grounds. It is only recently that this guiding principle has become smothered by impenetrable layers of scientific rationalism.—H.R.H Prince Charles. [Emphasis added]

Here biotechnology per se is a violation of nature. The mere presence of a transgene—even one that is utterly devoid of any negative effect—is nonetheless totally unacceptable. Ecclesiastical concepts of impurity, blasphemy, purity, sin, purging (even fire) are legitimate in social rationality regulation. The high-profile advocates of this approach include Vandana Shiva and Mae Wan Ho, who are frequent speakers at U.S. “sustainable agriculture” meetings. See, e.g., Center for Agricultural 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 social rationality regulation: that means its premise of technological precaution; speculative risk; transcendental issues; and the lynchpin of the school— the precautionary principle. Recently a second private members’ bill in the last few years was tabled and defeated in the federal Parliament of Canada. The genesis for the bill included the loss of export markets in flax after biotech flax (Triffid) commingled with export-bound flax. This bill attempted to displace science rationality with social rationality. The bill required a social economic review of GM crops prior to regulatory approval. Safety was not determinative. Instead, the bill sought regulatory recognition of overseas importers potential (social/ value) regulatory rejection and generally negative attitudes toward GM crops, and thus whether Canada should allow GM crops. The University of Guelph helped the defeat of this latest bill in part by explaining to members of Parliament the scientific need and risk assessment (RAF) of genetic modification.of crops. Perhaps this entire abstruse architecture of risk assessment schools and novel technologies can be distilled to two pithy questions: North America asks “why not?” and the EU asks “why?” Dr. Stan Benda, Ph.D. (Law) is presently in private practice in Toronto, Canada, as well as adjunct faculty, York & Ryerson Universities. He may be reached at [email protected].

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BELIEF

SCIENTIFIC RATIONALITY

SOCIAL RATIONALITY

Technological progress

Technological precaution

GENERAL REGULATORY ISSUES Type of Risk

Recognized / Probable

Risk Tolerance Science

Minimum risk Evidence-based/Safety, Health

Underpinning Theory Risk Assessment

Scientific

Focus

Product

Safety/Health

Recognized/Hypothetical Speculative Zero risk Social Construct/Ethics, Values Humanistic Safety/Health/Quality “other legitimate factors” Process/Production method

SPECIFIC REGULATORY ISSUES

Substantial Equivalence Risk Management (RM) Precautionary Principle Burden of Proof Structure Participation Labeling Objective of RM

Accepts

Rejects

RM is for risk reduction/prevention; safetyhealth basis Science-based (cost benefit)

RM is for social responsiveness; socioeconomic concerns Social-based (absolutist)

Innocent until proven guilty Vertical (existing structures) Narrow: Technical experts/Judicial decision making Safety- or nutrition-based—need to know Risk reduction/Prevention

Guilty until proven innocent Horizontal (new structures) Wide: Consensus, social dimensions Consumer right to know

 

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Socioeconomic concerns

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