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HomeMy WebLinkAboutCOM 0385.108 2012-2014 Page 1 of 1 Murashige, Laura From: Susan Miyasaka [sc_miyasaka©yahoo.com] Sent: Tuesday, September 03, 2013 10:01 AM To: counciltestimony©co.hawaii.hi.us Subject: Testimony against Bills 109 and 113 Attachments: Miyasaka_Testimony-against-Bill-113-all.pdf; Miyasaka-Testimony-against-Bill-109.pdf Dear County Clerk, Attached are my written testimonies against Bills 109 and 113. Thank you for your attention. Best wishes, Susan Susan C. Miyasaka P.O. Box 203 Pepeekeo, HI 96783 C7 cd..3 W -� O 3$5, /08 Comm. No. Ref. To: P/'JAI re-' Ref. Dote SEP 0 4 2013 9/3/2013 TO: Brenda Ford, Council Council Chair, Committee on Public Safety& Mass Transit Margaret Wille, Vice Chair, Committee on Public Safety & Mass Transit Karen Eoff, Member Greggor Ilagan, Member Dru Mamo Kanuha, Member Zendo Kern, Member Dennis "Fresh" Onishi, Member Valerie T. Poindexter, Member J. Yoshimoto, Member FROM: Susan C. Miyasaka, Ph.D. SUBJECT: Testimony against County Council Bill No. 113 My name is Dr. Susan C. Miyasaka, and I am an Agronomist at the University of Hawaii. I am providing testimony to you as a private individual and not as a representative of the College of Tropical Agriculture and Human Resources (CTAHR). My testimony is not biased by financial interests, because I have not received any research funding from any of the seed companies. County Council Bill 113 seeks to prohibit"the open air cultivation, propagation, or development of genetically engineered crops or plants," exempting genetically engineered papaya. This bill cites the precautionary principle "to guard against the intrusion of potential contaminants and prevent the contamination of non-genetically engineered crops, plants and lands by genetically engineered crops and plants without having to first wait for definitive science." Definitive science: I urge you to vote against Bill 113, because over 120 studies in reputable, peer-reviewed journals conducted by independent scientists have shown that genetically engineered (GE) crops approved by the U.S. Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration are `substantially equivalent' to non-GE crops. In other words, they are as safe for human consumption as non-GE crops. You can check these studies yourselves at the BioFortified website, a non-profit organization of independent scientists who are dedicated to educating the public about genetics and genetic engineering of crops: http://wvuw biotortified.ori;/genera/studies-for-genera/independentfunding/. In a recent review of the health impact of GE plant diets in long-term and multi-generational animal feeding trials, the authors concluded "Results from all the 24 studies do not suggest any health hazards..." (Snell and others, 2012). The American Medical Association's Council on Science and Public Health reported (2012)that"Bioengineered foods have been consumed for close to 20 years, and during that time, no overt consequences on human health have been reported and/or substantiated in the peer-reviewed literature." "The American Association for the Advancement of Science, the 'World Health Organization and the exceptionally vigilant European Union agree that GMOs are just as safe as other foods" (Scientific American, 2013). The official position of the American Dietetic Association (2006) is that"Agricultural and food biotechnology can enhance the quality, safety, nutritional value, and variety of food available for gY q Y Y Y 1 human consumption, and increase the efficiency of food production, food processing, and food distribution, and environmental and waste management." Problem with Precautionary Principle: The problem with using the precautionary principle is that it only considers the risks of new technologies without considering the benefits, such as reduction of current risks. In a recent Issue paper, the Council for Agricultural Science and Technology (which included 52 Task Force members), specifically looked at the risks and benefits of genetically engineered foods, and stated that the precautionary principle "has become unworkable and counterproductive" (CAST, 2013). Potential Benefits of Genetic Engineering of Crops: There are many positive benefits of transgenic crops that are being developed or are in existence, such as disease or pest resistance, drought resistance, high temperature tolerance, increased yield, and improved nutrition. I strongly encourage you to educate yourself further about the potential benefits of genetic engineering of crops. Mark Lynas, former anti-GMO activist, is now apologizing and saying that genetic engineering technology is science-based, safe for consumers, and needed to feed the world population and protect the environment. Watch the video of his speech at the Oxford Farming Conference held 3 January 2013: http://www.marklynas.org/2013/01/lecture-to-oxford- farming-conference-3 january-20l3/ Task Force or Ad-hoc Committee on Agricultural Sustainability and Co-Existence. Please form a Task Force or Ad-hoc Committee of farmers, ranchers, and scientists to discuss agricultural sustainability and co-existence of all types of farming systems. There is no scientific reason that co-existence cannot happen between organic and conventional farmers. We live among one of the most cultural diverse populations in the world, and we can serve as a model for how agricultural sustainability and co-existence can and should happen. Please vote `NO' on Bill 113. Instead, please form a Task Force or Ad-hoc Committee to make recommendations about Agricultural Sustainability and Co-existence of organic and conventional farmers on the Big Island. References: American Dietetic Assoc. 2006. Position of the American Dietetic Association: Agricultural and food biotechnology. Vol. 106, pg. 285-293. http://www.ncbi.nlm.nih.gov/pubmed/16442880 AMA (American Medical Association). 2012. Report of the Council on Science and Public Health. CSAPH Report 2-A-12. http://www.ama-assn.or g/resources/doc/csaph/a I2-csaph2- bioengineeredfoods.pdf. Council for Agricultural Science and Technology (CAST). 2013. Issue Paper: Impact of the Precautionary Principle on Feeding Current and Future Generations. No. 52, June 2013. http://www.cast- science.org/download.cfm?PublicationlD=276208&1 ile=I030d78edI63edb68af62c5c34344d6e 4379TR 2 Scientific American, The Editors. 2013. Labels for GMO Foods are a Bad Idea. Sept. 6, 2013. http://www.scientificamerican.com/article.cfm`'id==:labels-for-gmo-foods-are-a-bad-idea Snell, C., A. Bernheim, J.-B. Berge, M, Kuntz, G. Pascal, A. Paris, and A.E. Ricroch. 2012. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review. Food and Chemical Toxicology. 50:1134-1148. http:// ww.scienccdirect.com/science/article/pii/S027869 I5 1 1 006 399 3 1 ,.„, , CAST® Number 52 '`,„...„, Issue Paper June 2013 Impact of the Precautionary Principle ,, :fe on Feedin g Current and ,,s Future Generations ,, ---nro .1-651 ' ,° The Goldilocks Strategy may be the most appropriate when striving for a balanced and deliberate approach to precaution. (Photos from Shutterstock.) i; ABSTRACT growing population,the case studies importance of safety and give credit sy* center on agricultural issues such as to the general concept that sparked After a research-based analy- chemical use and genetically modi- the PP,but they indicate it has sis and peer-reviewed process,the fled foods.They use a quote to il- become unworkable and counterpro- authors of this CAST Issue Paper luminate their Catch-22 concern: "A ductive.A passage in the conclusion t ? make it clear: "The precautionary ban on genetic engineering of food illustrates this: "As with many things principle may is literally dangerous to people who in life,the Goldilocks strategy may rinci le ma well be the most in- novative,pervasive,and significant have a great deal to gain from genetic be most appropriate—not too little a new concept in environmental policy modification.The precautionary precaution,not too much,but just s5; over the past quarter century. It may principle forbids genetic modification the right amount is needed.If the PP ; . also be the most reckless,arbitrary, of food because it gives rise to risk, helps us to more consciously strive and ill-advised." Using data,specific but the precautionary principle also for such a deliberate and balanced examples,and case studies,the task forbids forbidding of genetic engi- approach to precaution,that might be s; , force members conclude with allu- neering of food because forbidding its most positive legacy." lions to a literary paradox,a child's genetic engineering of food gives rise The PP has played an important g,-,!' fairy tale,and a futuristic axiom to Y to risk"(Sunstein 2006b). part in bringing attention to appropri- make their points. The authors give examples of ate risk management.If it is applied The paper first looks at the his- the PP's failure to offer a credible in its more stringent formulations, tory of the precautionary principle and reasoned framework for the ap- however,the PP will suppress in- ,.. ° :3, (PP)and then examines problems plication of risk management.They novation,to the detriment of both `°, of ambiguity,arbitrary application, describe inconsistencies and suggest the economy and human health.For and bias against new technologies. that the PP will be increasingly con- example,a precautionary approach Because the publication is espe- troversial,marginalized,and ignored to managing the risks associated with . cially focused on the need to feed a in the future.They acknowledge the food irradiation sends a message r`°, This material is based upon work supported by the U.S.Department of Agriculture's(USDA)National Institute for Food and Agriculture(NIFA)Grant No. 2010-38902-20899.Any opinions,findings,conclusions,or recommendations expressed in this publication are those of the author(s)and do not necessarily ' ` reflect the views of USDA—NIFA,any other USDA agency,or the USDA. CAST Issue Paper 52 Task Force Members Authors Environment,Washington State Leen Hordijk,Joint Research Cen- University,Richland tre,European Commission,Brus- sels,L.Griffin,Plant E idemiol- sels,Belgium(retired) Gary Marchant(Chair),Sandra p Andrew LaVigne,American Seed Day O'Connor College of Law,Ari- ogy and Risk Analysis Laboratory, g zona State University,Tempe U.S. Department of Agriculture, Trade Association,Alexandria, Linda Abbott,Office of Risk As- Raleigh,North Carolina Virginia sessment and Cost-Benefit Analysis, Reviewers CAST Liaison U.S.Department of Agriculture, Washington,D.C. Richard Crowder,Department of Thomas P.Redick,Global Envi- Allan Felsot,Department of Agricultural and Applied Economics, ronmental Ethics Counsel,Clayton, Entomology and School of the Virginia Tech,Blacksburg Missouri that the technology is more danger- ture risks as well as provide impor- of new technologies and other driv- ous than the benefits.This assumption tant benefits.It is a general (although ers of productivity growth in food that acting to protect cannot result in not universal)observation that new and agriculture,food production will damage has led to a reluctance to use technologies tend to be safer than the not keep up with global food de- a technology that could actually be a older technologies they replace(Huber mand expansion that is being driven great benefit to food safety. 1983).Thus insufficient precaution by income and population growth. In many respects,the PP does would allow unacceptable existing and The global population is projected more harm than good.Of course, new risks to occur,whereas excessive to exceed 9 billion by 2050.Global commonsense safety practices are precaution is likely to make us less food demand is projected to double necessary,and these findings do not safe and prosperous by restricting ben- in that same time period,which will advocate reckless abandon. But the eficial new technologies.Finding the require significant increases in agri- future involves a mission to feed"a delicate balance between these unde- cultural productivity in all regions of population of 9.1 billion by 2050." sirable outcomes from too little or too the world(FAO 2009;Global Harvest The PP has failed as an overall risk much precaution is the goal of effec- Initiative 2012).New technologies,in management strategy,and it is time to tive risk management. combination with economic,social, move past it. Perhaps no risks—real or poten- and political advances,will be critical tial—have created more concern, to meeting this growing food demand. INTRODUCTION debate,and controversy than those In this highly polarized and con- relating to food.Food is obviously a tested field of managing the risks of Managing risks has become a cen- basic requirement for human survival. food,the concept known as the"pre- tral focus of modern society.Indeed, In recent years,food has also become cautionary principle"(PP)emerged the term"risk society"is often used a central focus of risk management. some 20+years ago.Originating pri- to describe modern life(Beck 1992). Highly publicized incidents of deaths manly in Europe,the PP has encoun- Successful management of risk or illnesses resulting from contaminat- tered a much more skeptical reception presents difficult challenges and re- ed foods in North America,Europe, in the United States and elsewhere, quires careful balance.On one hand, and China have increased public sen- although it has its supporters even in as our society becomes wealthier, sitivity about food safety.New tech- those areas.These different national healthier,and longer-lived,we are less nologies applied to food,such as food perspectives on the PP are causing tolerant to risks that could prematurely irradiation,genetic modification,and enormous disruptions in intemation- shorten or diminish the enjoyment of nanotechnology,have resulted in new al trade and markets at this time by our new prosperity.The development disputes about food safety.Trends producing inconsistent regulations on of powerful new technologies that toward organic,"natural,"and even food technologies such as genetically have the potential to create new and, unpasteurized food products evince modified crops,antimicrobial treat- in some cases,potentially irreversible not only social and philosophical con- ments in processing,chemical feed risks further enhances the need to bet- cerns but also worries of food safety additives in meat,and pesticides that ter manage risks.On the other hand, and new food technologies by vocal are resulting in unjustified and harmful overly restrictive risk management segments of the populations of devel- trade restrictions.Almost every new will suppress innovation and impede oped nations. agricultural and food technology be- new technologies that may lessen fu- At the same time,without adoption ing developed for the future is likely 2 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY ,IIIIIIIIIIIIIIIIIIIIIIImmmmllIllIllIllIllP NI to face similar restrictions if the PP into international prominence with Textbox 1. Some factors explaining continues to block new technologies. two important developments in 1992. rise of the PP. These and other PP-related contro- First,the United Nations Conference versies threaten to derail the new free on Environment and Development Record of past risk management trade agreement that is being negotiat- (UNCED)endorsed a relatively weak failures ed between the European Union(EU) version of the PP,which remains the Growing mistrust of government and and the United States.As the German only version supported by the United industry Foreign Minister,Guido Westerwelle, States to this date(UNCED 1992). Rapid development of many new recently warned,the"treaty cannot fail Second,the EU adopted the PP into "exotic"technologies(e.g., geneti- because of chlorinated chickens this the 1992 amendments to the Treaty of cally modified organisms[GMOs], time"(Pauly and Schult 2013).There Rome,the foundational treaty of the nanotechnology, synbio) has thus never been a more urgent EU,making it a binding principle of Increased uncertainty about new need or time to clarify the role of,and EU environmental law. Subsequent risks resolve the controversies over,the PP. interpretations of this provision by Outdated laws and risk regulatory This Issue Paper seeks to under- the European Commission and the approaches stand and evaluate the PP,especially European Court of Justice expanded Increased role for nongovernmental as it applies to food.The paper first the scope of the PP to apply to all en- organizations(NGOs)on scientific summarizes the history,objectives, vironmental,health,and safety regula- and risk issues and limitations of the PP,then consid- tory decisions in the EU. Can be used as a protectionist trade ers three case studies in which the PP The EU did not define or explain tool has been applied to food,and con- the PP when it adopted it as a manda- cludes with some recommendations tory legal requirement,simply stat- on how the controversy over the PP ing that"the precautionary principle" avoided answering critical ques- might be resolved. shall apply.Eight years after adopt- tions about its application,such as ing the PP,the European Commission what quantum of evidence of risk THE PRECAUTIONARY published the most extensive offi- is needed to trigger the PP or what cial explanation of the principle to level of risk is acceptable under the PRINCIPLE: HISTORY AND date in its 2000"Communication" PP.The Commission explained that OBJECTIVES on the PP(Commission of the such questions were"political ques- The PP concept has received in- European Communities 2000).The tions"to be decided on an ad hoc Communication expressly stat- basis by politicians or regulators.The creasing attention around the globe, ed that the PP applies in the risk Commission's construction of the PP stirring both support and contro- versy in each jurisdiction and con- management rather than risk assess- in its Communication,such as its re- text in which it has been adopted or ment stage of decision making,to be quirement that the application of the proposed.This section describes the applied only after the fullest pos- PP be based on cost-benefit balanc- tumultuous rise and spread of the PP sible scientific assessment of risks. ing,was vociferously opposed by (see Textbox 1),the arguments sup- The Communication also set forth many proponents of the PP in the EU criteria for application of the PP, Parliament,by numerous environ- porting its rapid proliferation,and the including that actions taken pursu- mental and citizens'groups,and else- growing resistance and declining mo- ant to the PP must be"proportional where(ENDS Europe 2000; Lofstedt mentum the PP is now facing. to the chosen level of protection; 2004).After facing so much opposi- Histary of the Precautionary non-discriminatory in their applica- tion and controversy to its initial at- PrinCl le tion;consistent with similar measures tempt to explain and operationalize already taken;based on an examina- the PP,the Commission has refrained The PP emerged in the latter de- lion of the potential benefits and costs from any further concerted attempts cades of the 20th century as an over- of action or lack of action(includ- to elucidate it. arching philosophy of prudent cau- ing,where appropriate and feasible, While the EU has been the global tion in the environmental programs of an economic cost/benefit analysis); leader in adopting and promoting the nations such as Germany and Sweden. subject to review in the light of new PP,other nations have also adopt- After then being incorporated into scientific data;and capable of assign- ed it by legislative action or judicial several relatively unknown regional ing responsibility for producing the opinion,including Australia,Canada, and international treaties primarily scientific evidence"(Commission of India,Japan,and New Zealand.The relating to marine protection and be- the European Communities 2000). PP has also been incorporated into ing proposed for others(Freestone Although advancing understand- more than 60 international envi- and Hey 1996; Lofstedt,Fischhoff, ing of the PP,the Commission's ronmental agreements(Trouwborst and Fischhoff 2002),the PP jumped Communication did not define it and 2007).More recently,a small number COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 3 of U.S.municipal governments,in- Textbox 2. Precaution terminology. on the PP to justify restrictions on cluding San Francisco and Seattle, --- genetically modified(GM)food ex- have adopted the PP into their local Precaution:As defined by Web- ports from nations such as the United laws.As was the case with the EU, ster's dictionary, "a measure States,Canada,and Argentina(WTO none of the legal adoptions of the PP taken beforehand against pos- 2006),I Bible danger." include a specific definition of it. Even the EU has moderated its Precautionary Approach:A regula- application of the PP(Lofstedt 2004), tory approach, such as that ap- Rationales for the plied by the United States,that recognizing that in"the real world of Precautionary Principle seeks to err on the side of safety multiple risks,the PP must be quail- by applying precaution informally fled by the recognition that there are aphorism that it is better to be safe and implicitly in regulatory real costs of excessive precaution: decisions. False positives,cost,inhibited inno- than sorry and that some degree of Precautionary Principle:A legal vation,and the countervailing risks precaution is appropriate,indeed es- " sential,for any meaningful regulatory requirement, such as that en- of regulatory interventions"(Wiener Y g g ry acted by the EU,that mandates 2002).The EU courts are increas- program.Given the inevitable scien- the formal and explicit applica- ingly reining in the PP,requiring its tific uncertainty that surrounds most tion of precaution in regulatory application to be preconditioned on environmental,health,and safety decisions. risks,it would be unacceptable to re- a scientific risk assessment,the very quire regulators to wait for absolute requirement that most nongovern- mental proponents of the PP sought certainty of harm before undertak- et al.2001).Frequently cited ex- to replace with the PP(Stokes 2008). ing any protective measures,includ- ampler include asbestos,lead,and The EU has recently launched several ing delaying a potentially dangerous polychlorinated biphenyls or PCBs. major new regulatory process initia- technology or product until additional The PP seeks to reverse the falla- tives referred to as its"Better/Smart safety data are produced.Indeed,ev- cy that absence of evidence of haz- Government"and"evidence-based ery regulatory system necessarily has and is evidence of absence of hazard policy"agendas that appear to at least exercised some degree of precaution. (Grandjean 2005).A number of other implicitly diminish and de-emphasize The U.S.government,for example, factors(see Textbox 1),relating both the role of the PP.For example, has taken the position that it applies to the nature of scientific uncertainty in its 2004 Communication titled a"precautionary approach" in mak- and the perceived inadequate regula- Towards a European Strategy for ing regulatory decisions.In the words tory response to many technological Nanotechnology,a critical document of one U.S.government official,"the risks,have also contributed to the rise that set forth the European regulatory US government supports precaution- of the PP(Ashford 2007;Lofstedt, approach to nanotechnology,the EU ary approaches to risk management, Fischhoff,and Fischhoff 2002). Commission rejected calls for a mora- but we do not recognize any universal torium on nanotechnology and made precautionary principle.We consider Growing Resistance and very little reference to the PP,other it to be a mythical concept,perhaps Flagging Momentum than to state that the"Precautionary like a unicorn"(Graham 2002). The PP,as adopted by the EU, Although the PP has experienced Principle,as used up to now,could purports to go beyond the precaution- a swift rise over the past two decades be applied in the event that real- ary approach employed by the United since its breakthrough in 1992,its ex- istic and serious risks are identi- States to apply precaution more defin- pansion and acceptance has stalled in fled"(Commission of the European itively and aggressively(see Textbox recent years(Lofstedt 2004).It is in- not 2004).The to should creasingly encountering criticisms that not be necessary to regulate"realistic 2).The PP changes two things: first, g Y g and serious risks"—they should and ! it tries to make explicit the typically it is antiscientific and economically Y implicit application of precaution,a damaging.Despite concerted efforts likely would be addressed under any largely unobjectionable goal;and sec- by the EU and advocacy organiza- regulatory system.2 ond,and more controversially,it seeks tions,the United States has steadfastly Moreover,attempts by nations to increase the amount of precaution refused to accept the PP as a formal applied. requirement at the federal level un- t The World Trade Organization held that world trade law does not sanction GM food trade restrictions der both Republican and Democratic The PP's call for greater precau- p based on the PP.Because these nations are not parties tion is premised on the history of pre- administrations.Likewise,the PP has to the Cartagena Protocol on Biosafety,they are also viously suspected hazards that were made only minor progress in being not subject to the precautionary approach to trade in adopted at the state and local levels. GM products imposed on parties under that protocol. not regulated until extensive harm P The World Trade Organization has The European Parliament has recently advocated to human health and the environ- g more restrictive policies on nanotechnology in prod- ment had been inflicted (Harremoes rejected the EU's attempted reliance ucts such as food and cosmetics based on the PP. 4 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY Ai such as France and Italy to adopt Textbox 3. Disparate definitions of 1982 World Charter for Nature,which precautionary policies that prohibit the PP. requires that"where potential adverse GM products approved by the EU _ effects are not fully understood,the have been consistently rejected by United Nations Conference on activities should not proceed"(United Environment and Develop- the European Court of Justice(ECJ ment(UNCED 1992) Nations General Assembly 1982). 2012).The United Kingdom House Where there are threats of seri- Because the"potential adverse ef- of Commons Science and Technology ous and irreversible damage, fects"of no technology or product are Committee recommended that the use lack of full scientific certainty "fully understood,"this version of the of the term"precautionary principle" shall not be used as a reason for PP would seemingly ban anything to should cease because of its persis- postponing cost-effective mea- which it is applied(Foster,Vecchia, tent ambiguity(United Kingdom sures to prevent environmental and Repacholi 2000). House of Commons Science and degradation. In fact,there are dozens of ver- Technology Committee 2006).Or,as Wingspread Definition (Raffens- sions of the PP,differing significant- one of the leading and most respect- perger and Tickner 1999) ly in multiple dimensions(Sandin ed EU experts on administrative law, When an activity raises threats 1999).One level of ambiguity of the Gianomenico Majone,recently wrote, of harms to human health or PP,therefore,is the lack of an official the environment, precaution- the EU's regulatory actions"such as ary measures should be taken definition and the important variations the strenuous advocacy of the pre- even if some cause and effect in the many unofficial versions,none cautionary principle—appear to be relationships are not fully estab- of which have any application prece- manifestations of an infantile disorder 1 lished scientifically. dence.A regulator could choose to ap- of risk regulation rather than progres- i World Charter for Nature(United ply any of the existing versions,with- sive moves"(Majone 2010).Although Nations General Assembly out even stipulating which version is the meteoric rise of the PP appears to 1982) being applied.Indeed,regulators rou- have stalled and may even be retreat- Activities which are likely to pose tinely state they are applying"the"PP, ing,the PP is still having an enor- a significant risk to nature shall but there is no"the" PP—there is only mous impact on regulatory decisions, be preceded by an exhaustive a multitude of different unofficial ver- international trade,and technological examination;their proponents sions with critical variations in word- , innovation.Unfortunately,for reasons shall demonstrate that expected ing,meaning,and application. discussed later,these impacts of the benefits outweigh potential A second level of ambiguity of the PP are mostly negative. damage to nature, and where pp is that none of the many unofficial potential adverse effects are not fully understood,the activities definitions answer essential questions PROBLEMS WITH THE should not proceed . . . that are critical to rational risk regu- ___ lation.For example,none of the PP PRECAUTIONARY PRINCIPLE versions answer questions such as the A number of criticisms have been proponents gathered at a conference following(Bodansky 1991;Marchant leveled against the PP,the three most center in Wingspread,Wisconsin, 2003): (1)What level and types of common being(1)the ambiguity and in 1998("Wingspread definition"; evidence are needed to trigger the lack of definition of the PP; (2)the see Textbox 3).The UNCED defini- PP?(2)What level of risk is accept- arbitrariness and unprincipled ways tion,described as"wimpy"by one PP able under the PP?(3)How should in which the PP has been applied;and proponent(Cranor 2004),is stated in the costs(including opportunity costs) (3)a bias against new technologies. permissive language,applies only to of risk reduction or risk avoidance be serious and irreversible risks,requires factored into the decision,if at all? Ambiguity any precautionary action to be"cost (4)How should"risk-risk"trade-offs Although many jurisdictions,led effective,"and is addressed to risks or the risks from not adopting a new by the EU,have adopted the PP as where there is a"lack of full scientific technology be factored in and man- a legal requirement,none have of- certainty."In contrast,the Wingspread aged?(5)What type of action does the ficially defined it.There are many definition is stated in affirmative and PP require? semiofficial and unofficial definitions mandatory language,applies to any A third level of ambiguity con- that have been offered,but these dif- risk whether serious and irrevers- cerns differences in the understanding fer in significant ways,even if they ible or not,contains no requirement of the intended purpose and status of seem roughly similar on first impres- that actions be cost effective,and ap- the PP.Depending on the source,the sion (see Textbox 3).For example, plies"even if some cause and effect PP is sometimes construed as a gener- compare the 1992 UNCED defini- relationships are not fully established al philosophy,a rhetorical statement, tion with that adopted by a work- scientifically."An even more extreme an informal rule of thumb,a risk man- shop of leading nongovernmental PP version of the PP is provided in the agement decision rule,or a legally COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 5 binding requirement(Marchant 2003; its"Communication"that resulted used to justify protectionist policies. Starr 2003;Weed 2002). in widespread disagreement among Thus the PP was invoked by Norway Some proponents, including the PP proponents—and it appears that and the Netherlands to ban Kellogg's EU,contend that the PP is only to any further official attempts to define Corn Flakes®allegedly because the be applied at the risk management or refine the PP officially have been added vitamins could potentially harm stage after a scientific risk assess- abandoned. susceptible individuals,and Denmark ment(Chapman 1999;Commission relied on the PP to ban Ocean Spray of the European Communities 2000), Arbitrary Application Cranberry®drinks because the added whereas other proponents of the PP Given the ambiguity in the defini- vitamin C could also potentially harm state that it should also apply to risk tion,meaning,and application of the susceptible individuals(Marchant and assessment(Cranor 2004;Santillo et PP,it is not surprising that the PP has Mossman 2004).Both decisions had al. 1998).More broadly,some argue been applied arbitrarily(Marchant the effect of excluding an American that the PP is complementary and and Mossman 2004).To be sure,the product from European markets to should be part of the traditional risk PP is cited in many regulatory deci- the benefit of domestic competing assessment/risk management frame- sions that are relatively uncontrover- products. Both decisions were sub- work that has been used for decades sial and likely would have been made sequently struck down by courts as by regulatory agencies(Commission with or without the PP.But in other thinly disguised protectionist mea- of the European Communities 2000; cases,political factors appear to be sures that lacked any scientific sup- Goldstein and Carruth 2004),whereas the only explanation for why the PP port(Marchant and Mossman 2004). others contend that the PP is antago- is applied to some risks but not others In other cases,the protectionist intent nistic to the traditional risk assess- (see Table 1).At least some govern- may be harder to demonstrate but can ment/risk management framework ment officials recognize this potential nevertheless have enormously de- and is an alternative to that frame- for mischief in the PP.For example, structive consequences for the econo- work(Cranor 2004; Kriebel and the EU Commissioner for Health my and human health(Goldstein and Tickner 2001). Some proponents and Consumer Protection,David Carruth 2004). argue that the PP shifts the burden Byrne,stated in 2004,"I am no fan Another important factor influenc- of proof to the manufacturer of a of the indiscriminate use of precau- ing application of the PP is the actions product(Raffensperger and deFur tion.Precaution in this sense can be of NGOs that target certain products 1999),whereas others argue that a thinly disguised trade protection that they politically oppose for special such a shift is infeasible(Trouwborst measure,not to mention a badge of treatment under the PP.For example, 2007).Some contend that the PP political cowardice,"and he cau- there is strong pressure to apply the should only apply to irreversible or tioned that the PP is not intended to PP to restrict GM foods but not food catastrophic risks (Sunstein 2006a), be"a joker or wild card that can be manipulated in similar,though non- whereas others respond that the PP played at any moment as a pretext for genetic engineering,ways.As a case should not be so limited (Ashford unjustified measures"(Byrne 2004). in point,herbicide-resistant crops 2005).Some argue that the PP implic- Notwithstanding such warnings,some created by genetic engineering and itly incorporates cost-benefit analy- EU entities have used the PP for inap- non-genetic engineering techniques sis(Commission of the European propriate or unjustified restrictions on exhibit similar environmental and Communities 2000; Farrow 2004); products and technologies. health risks,but the PP is selectively others argue that it is an alternative to For example,the PP is sometimes being applied only to the GM versions cost-benefit analysis (Ashford 2007; ENDS Europe 2000). Table 1. Some dubious applications of the precautionary principle The inherent ambiguity of the PP has been known and criticized for Jurisdiction Action Based on PP Rationale many years(Bodansky 1991).Other Norway Banned cornflakes fortified with vitamins Vitamins may harm susceptible individuals regulatory principles(e.g.,cost-benefit Authority v.(Norway 0011)ance analysis)also involve some ambiguity France Banned caffeinated energy drinks Pregnant women may consume but are gradually defined and imple- too much caffeine(Commission mented through the development of v. France 2004) more detailed criteria and guidelines. Denmark Banned cranberry juice drinks with extra Some individuals may be The PP is unique in that there has vitamin C susceptible to vitamin C been no official attempt to"operation- (Commission v.Denmark 2003) alize" it through adoption of criteria EU Justifying subsidization of coal extraction None given(European Union 2001) or guidance—other than some initial Zambia Rejection of U.S.food aid during famine U.S.corn may contain genetically steps by the EU Commission with modified kernels(Bohannon 2002) 6 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY (Morris 2007).Similarly,many foods products,which is not surprising clean energy technologies(Marchant are created by nuclear or chemical given that the primary orientation et al.2012).It is therefore quite pos- mutagenesis,producing greater num- of the PP is prevention of new risks sible,if not probable,that the calls to hers of unknown mutations than the when there is significant uncertain- put a moratorium on all nanotechnolo- more precise GM methods (Batista et ty(Weiss 2003).A generic focus on gy products based on the PP would do al.2008),yet they escape calls for ap- new products is problematic because more harm than good to public health plication of the PP. they often present lower risks than and the environment. Regulators ap- As a general matter,the PP is of- the older products they are intended plying the PP rarely consider the risk- ten applied selectively to"exotic" new to replace(Huber 1983; Marchant, reducing potential of new technolo- technologies,such as genetic modifi- Sylvester,and Abbott 2009; Sunstein gies and instead focus solely on the cation,nanotechnology,and synthetic 2005),and failing to adopt new prod- risk-creating potential,thus result- biology,that are often sensationalized ucts can increase risks.Regardless of ing in a skewed and potentially self- (both the risks and benefits)in the whether the subject is automobiles, defeating decision(Miller and Conko news media.Research on public per- pharmaceuticals,pesticides,factories, 2001; Morris 2002). ceptions of risk demonstrates that the or a myriad of other products,new The PP may also do more harm public is more concerned about and technologies are generally safer than than good by placing an impossible or tends to inflate the risks of technolo- the older versions.By imposing a bar- highly burdensome impediment in the gies that are unfamiliar and uncertain, rier to the introduction of newer tech- pathway of the development of new triggering"dread"responses(Slovic nologies,the PP favors the status quo, technologies.As two scholars noted 1987).The extent to which public which could often mean higher risks (Holm and Harris 2000): perceptions should govern application (Sunstein 2005). As a principle of rational choice, of the PP is one of the most important There is another problem concern- the PP will leave us aral sed. P Y and controversial aspects of the PP, ing how the PP treats new technolo- In the case of genetically modi- especially w hen public perceptions gies.Ma n y emerging technologies, fled(GM)plants,for example,the are inconsistent with scientific assess- such as biotechnology,nanotechnol- greatest uncertainty about their ments of risk.Some governments seek ogy,and synthetic biology,are prime possible harmfulness existed be- to reassure the public about new tech- targets of the PP because unfamiliar- fore anybody had yet produced nologies by invoking the PP to apply ity increases uncertainty.Thus,po- one.The PP would have instruct- precautionary measures,but empirical litical opposition by NGOs is facili- ed us not to proceed any further, studies show that such applications of tated by invoking the strong PP.Yet and the data to show whether the PP backfire and have the effect of these emerging technologies present there are real risks would never increasing rather than calming public potential environmental and health have been produced.The same fears about a technology(Wiedemann benefits in addition to possible risks. is true for every subsequent step and Schutz 2005). It is therefore not obvious whether in the process of introducing GM There are other examples of ar- restricting such a technology under plants.The PP will tell us not to bitrary application of the PP that are the PP will increase or decrease net proceed,because there is some only possible because of the lack of risks(Goklany 2001).The PP is thus threat of harm that cannot be any coherent definition or criteria for incoherent.For example,a"ban on conclusively ruled out,based on application of the PP(Marchant and genetic engineering of food is literally evidence from the preceding step. Mossman 2004)(see Table 1).For dangerous to people who have a great The PP will block the develop- example,the EU inexplicably justi- deal to gain from genetic modifica- ment of any technology if there is fled subsidization of the coal industry tion.So ... the precautionary principle the slightest theoretical possibility based on the PP(Trouwborst 2007), forbids genetic modification of food of harm. and the government of Zaire denied because it gives rise to risk,but the ' its own starving population U.S.food precautionary principle also forbids In other words,if taken and ap- aid based on the PP because of the po- forbidding of genetic engineering of plied in its more stringent formula- tential for trace amounts of GM corn food because forbidding genetic en- tions,the PP will suppress innovation, kernels,something the U.S.popula- gineering of food gives rise to risk" to the detriment of both the economy tion had been consuming for many (Sunstein 2006b). and human health."Because risks years(Goldstein and Carruth 2004; Another example of the incoher- are everywhere,the Precautionary Mallaby 2002). ency of the PP is the use of nanotech- Principle forbids action,inaction and nology to develop important cancer everything in between.It is therefore Bias against New Technologies therapies and other medical interven- paralyzing;it bans the very steps that it tions,new environmental remediation mandates"(Sunstein 2004).Moreover, The PP is applied dispropor- ( tionately to new technologies and approaches,and components in most the more stringently the PP is applied, COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 7 o the more likely such application is to yield at a rate similar to the global Now consider the regulatory ap- create countervailing risks: "as we try growth in food demand will require proach facing pesticide development to squeeze out more and more risk,the significant reductions in current yield and use in the United States. It can pressure leading to side effects may gaps,3 the gap between the aver- be argued that a precautionary ap- grow"(Graham and Wiener 1995). age and potential crop yield(Lobell, proach flows through the procedural Given the many potential negative Cassman,and Field 2009).Losses due requirements for U.S. pesticide regis- consequences that the PP is likely to to insects,diseases,and weeds con- tration (Applegate 2000).All pesti- have on human health and the envi- tribute to this yield gap.Current esti- cides sold,distributed,or used in the ronment,it fails its own test at least in mates of average yield gaps through- United States are required to have its present undefined and ambiguous out the world range from 20%to a valid registration prior to entering status,as it cannot demonstrate that it 80%of the potential yields(Lobell, the marketplace(United States Code, will not cause any adverse impacts and Cassman,and Field 2009). Title 7,Section 136a [aJ).Under therefore,according to its own dic- Pesticides have played a signifi- the Federal Insecticide,Fungicide, tates,should be prohibited.As Michael cant role in increasing crop yields. and Rodenticide Act(FIFRA),the Crichton wrote in State of Fear,the Since World War II,food production Environmental Protection Agency "`precautionary principle,'properly and demand have kept pace with one (EPA) has the sole authority to grant applied,forbids the precautionary another largely because of innovation such registrations. Risks to hu- principle"(Crichton 2004). in science and technology,including man health and the environment are agrochemicals(Godfrey et al.2010). evaluated before new products are The percentage contribution of pes- registered. FOOD CASE STUDIES: ticides in decreasing global potential In 1996,the Food Quality PRECAUTIONARY PRINCIPLE yield losses was estimated in 1993 at Protection Act(FQPA)added a new DOING MORE HARM THAN 35 to 38%for rice,wheat,and maize, periodic review for all pesticides. and at 43%for soybeans and pota- Even those pesticides with valid reg- GOOD? toes(Oerke and Dehne 1997).Even as istrations when the FQPA was enacted In this section,three case stud- Earth's climate changes,it is expected must be reexamined under the act's ies involving the application of the that further crop yield increases are new risk-based registration approach PP to food-related risks are evaluated. likely in some areas because of im- (United States Code,Section 136a [b] These three studies are(1)agricultural proved climates for plant growth,but [2] I B I Iv I).The FQPA also requires chemicals,(2) genetically modified also in other areas through a combina- examination of potential impacts of foods,and(3)food irradiation.The tion of plant breeding and the contin- pesticides on vulnerable subpopula- studies permit a real-world assessment ued availability of control techniques tions,such as infants and children. of the pros and cons of the PP for for pests,diseases,and weeds (see, During registration,the EPA must managing food-related risks. for example,Jaggard,Qi,and Ober ensure that the pesticide will cause no 2010). unreasonable adverse effect on human By 2050,there will not only be an health or the environment once the Agricultural Chemicals increased demand for food but also product is registered and used accord- Although the United States does a change in dietary composition,fu- ing to label directions.Registrants not explicitly apply the PP in regulat- eled by a demand for more energy- must submit data from a battery ing pesticides,it does apply a precau- rich foods like meat(Godfrey et al. of required tests(Code of Federal tionary approach,particularly since 2010;Seufert,Ramankutty,and Foley Regulations,Title 40,Section 1.58) statutory changes were adopted in 2012).Animal production also bene- prior to registration.The default con- 1996.This case study demonstrates fits from pesticide technology because dition in absence of satisfying the data some of the problems of applying an higher yields for feed crops and the requirements is prohibition of sale of overly stringent and narrow precau- control of disease vectors lower the the product as a pesticide. tionary approach.As a backdrop to costs of production and decrease the Pesticide registration in the United evaluating the consequences of a pre- prevalence of animal disease.In short, States also exhibits a precautionary cautionary approach in the evaluation pesticides will continue to be neces- approach to risk management,more of pesticides,consider several pro- sary as the burgeoning world popula- evident after the passage of the FQPA. jections of world population growth tion and income growth increase the New science policy guidance was and food demand. By 2050,feeding a demand for food. created to implement the FQPA's re- world population of 9.1 billion people quirement allowing residues on food will require raising current levels of s Italicized terms(except genus/species names,pub- only if"there is a reasonable certainty food production by approximately lished material titles,legal case names,and quoted that no harm will result from aggre- 70%(FAO 2009). Improving crop material)are defined in the Glossary. gate exposure to the pesticide residue, 8 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY including all anticipated dietary ex- reveals that differences in relative modity markets where no fumigant posures and all other exposures for precaution depend more on the issue- other than sulfuryl fluoride is avail- which there is reliable information" specific context of the risk than on able or economically feasible to use. (United States Code,Title 21,Section broad differences in national regulato- The cost of registration may 346a [b] [2] [A] [ii]). Precaution is ev- ry regimes(Wiener and Rogers 2002). prevent some products from being ident in pesticide risk assessment and In one of the few empirical treatments manufactured.Food uses are limited risk management not only from adher- of precaution in risk management,a by a maximum dietary exposure for ence to formal risk assessment guide- comparison between the United States all uses no greater than the refer- lines but also from the discretionary and the World Health Organization ence dose.Registering a pesticide judgment exercised by the assessors (WHO)standards—reference doses with food uses may cost more than (Brock et al.2003).The uncertainty and acceptable daily intakes used $9,000,000 to comply with the tests associated with the numerous choices, to establish negligible risk levels in required(USEPA 2011).The registra- both small and large,that assessors food—suggests that the U.S. regu- tion process may be too time con- make is not often systematically iden- latory approach is more stringent suming and costly for registrants to tified,and their combined effect is not than the WHO policy(Gray 2004). support pesticides for uses with small evaluated. Regulatory thresholds for the same markets not likely to generate enough Between 1999 and 2006,the EPA pesticide,based on the same input revenue to justify the cost of registra- reassessed 99%of the tolerances on data,were lower in the United States. tion.Pesticide registrations are crop food,modifying 12%and revoking Lower reference doses may translate or use specific;each crop constitutes 33%(USEPA 2012a).Although the into fewer allowable dietary uses for a separate use as well as a separate FQPA decreased exposure to pesti- the pesticide or decreased application market.There is a real possibility of cide residues(USEPA 2012b),it also rates.If precaution can be measured not having products to protect impor- impacted registration.The influence as regulatory stringency,then U.S. tant agricultural sectors against certain on registration can be coarsely exam- pesticide tolerances appear to be more types of pests.Specialty crops(fruits fined by comparing the rate of product precautionary than the comparable in- and vegetables)appear to have dispro- removal from and entry to the market ternational (WHO)standards(Brock portionately lost registrations relative since implementation of the FQPA.Of et al.2003). to larger commodities such as corn or the 16,952 products that have com- As a specific example,the pro- wheat(USEPA 2012e). pleted reregistration,4,742 were re- posed revocation of sulfuryl fluoride As this discussion demonstrates, registered, 10,571 were cancelled or tolerances in 2012(USEPA 2012d) pesticide registration in the United suspended,and 1,639 were amended illustrates an unintended consequence States incorporates a precaution- (USEPA 2012c). New active ingredi- of the new risk-based requirements ary approach with respect to the ents and new uses have been regis- of the FQPA.Reevaluation of the environmental and human health risks tered,but it appears not to be at the toxicological endpoint for fluoride from pesticide use.Yet the U.S. regu- same rate at which products were can- resulted in a reassessment of the cu- latory system does not examine risks celled or suspended.Between 2005 mulative and aggregate risks from of not using the pesticide with the and 2007,4,065 pesticide registration fluoride-containing pesticides.The to- same degree of rigor.Precautionary actions were completed.These in- tal fluoride exposure from all sources approaches that focus only on the eluded 156 new active ingredients and (water,food,toothpaste,soil,and pes- "target" risk—here,the risks due to 457 new uses for previously registered ticides)exceeded the new reference pesticide use—are prone to neglect active ingredients(USEPA 2008).The dose,causing the proposed revoca- adverse effects related to decreasing data on reregistered formulated prod- tion of tolerances for sulfuryl fluoride. the target risk on other aspects of the ucts and new decisions are not report- Sulfuryl fluoride is a stored product system or"system neglect"(Sunstein ed using the same metrics or over the fumigant that has increased in agricul- 2003).Uncontrolled pests and diseas- same time period,making this corn- tural importance as methyl bromide es may threaten human health,the en- parison inexact. uses have been curtailed to decrease vironment,or food security.Pesticides Quantitative examination of regu- risk of stratospheric ozone depletion. may decrease the disease risk to ani- latory thresholds used in risk man- The reasonable certainty of no-harm mals,plants,and humans through vec- agement reveals an additional pre- test in the FQPA required revocation tor control or disinfection.Pesticides cautionary approach resulting from of sulfuryl fluoride,even though all eradicate or suppress invasive species the discretionary choices made by other fluoride sources contribute more that impact native species,change assessors (Gray 2004). European than 97%of total fluoride exposure; the species composition of environ- countries are generally considered to revoking sulfuryl fluoride tolerances ments they occupy,and alter nor- embrace the PP more vigorously than will not appreciably decrease risk and mal functioning of the ecosystem.As the United States,although analysis will likely result in disruption to corn- noted in the Office of Management COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 9 , air , It i and Budget's(OMB's)memorandum cultivation)to support the world's consequences?(4)From an examina- on risk analysis principles,agencies crops are important,the genome of Lion of the spread of transgenic crop should seek to offer the greatest net the cultivars is critical to yield poten- technology,has the PP really affected improvement in welfare and account tial.Prior to the new techniques of introduction of the new crops? for a broad range of social and eco- transgenic engineering(i.e.,specific nomic considerations when choos- transfer of a gene from one species The Nature of Crop Biotechnology ing among alternative approaches to into another species accompanied by decreasing risk(OMB/OSTP 2007). stable expression),not much attention Before addressing pertinent ques- "Welfare" is defined by the OMB to was paid to environmental or social tions about GMOs and regulation include considerations"such as eq- consequences of plant breeding. under the perspective of the PP,the uity,quality of life,individual prefer- Yet the ongoing mystery of DNA technology of genetic engineering ences,and the magnitude and distribu- (deoxyribonucleic acid) biochemis- needs some explication.Concisely Lion of benefits and costs(both direct try in the mind of the general public defined (Ronald 2011),genetic engi- and indirect,both quantifiable and and misunderstanding of basic scien- neering of crops is distinguished op- non-quantifiable)." tific principles have surely contrib- erationally from conventional breed- Organic agriculture is often cited uted to feelings of uncertainty and ing methods.Genetic engineering is as a solution for feeding an increas- unease concerning the new breeding a method allowing the introduction ing global population(Seufert, techniques of agricultural biotechnol- of one or a few well-characterized Ramankutty,and Foley 2012).Crop ogy.This uneasiness has influenced genes from just about any species into yields are,on average,25%lower for government policy in many parts of a host plant.In contrast,conventional organic systems compared to simi- the world to invoke the PP in making breeding methods create new vari- lar conventional agriculture systems, decisions about commercialization of eties of plants by mutating or intro- although local differences vary con- transgenic crop plants.In the case of ducing many uncharacterized genes siderably depending upon the agro- the EU,this application of the PP has into the same species(Ronald 2011). 1 ecosystem type.Yield differences resulted in severe restrictions on ap- Indeed,recent research shows that may be as high as 34%for the most proval and availability of GM crops, conventional breeding methods prob- comparable organic and conventional food,and feed.A variety of social and ably cause more mutations in a new systems.Differences in pest pressure economic factors underlie the EU's cultivar's genome than breeding by between the systems could not be di- resistance to GM crops and foods, focused genetic engineering(Batista rectly examined but may have contrib- including public concerns about the et al.2008; Ricroch,Berge,and uted to the yield differences(Seufert, risks of GM foods,the recent history Kuntz 2011).Furthermore,environ- Ramankutty,and Foley 2012). of risk management fiascos involving mental conditions influence genetic Many different agricultural tech- foods(e.g.,mad cow disease),dis- expression and compositional differ- niques,including both organic and con- trust in regulatory institutions for food ences more than the process of genetic ventional as well as possible hybrids safety,and protectionist sentiments on engineering itself(Frank et al.2012). of the two systems,will be required to behalf of EU farmers. Because the philosophy embed- produce food for future generations at The concern among advocates ded in the PP seems singularly applied affordable prices and decrease envi- for agricultural biotechnology as the only to genetically engineered crops ronmental agricultural costs.Applying breeding paradigm of the future is that and not to conventional breeding a highly precautionary regulatory ap- society ruled by the PP will be miss- techniques(Morris 2007),advocates proach on a pesticide-by-pesticide ba- ing many of the benefits of a proven seem to assume that something very sis or within a common mechanism of technology.This fear raises four per- new or perhaps unnatural has been in- action group does not provide an effi- tinent questions discussed later: (1) vented and thus uncertainty about its cient framework for evaluating the risk Are the details of genetic modification hazards is high—i.e.,the potential for to agriculture of not having a robust set using recombinant DNA technology catastrophic consequences is inferred. of pest management products to con- understood as necessary before any This premise is misinformed.For ex- trol pests or diseases. type of regulatory approach is imple- ample,special pieces of a plant's own mented?(2)How are GMOs regu- DNA called transposons are known to lated under application of the PP and periodically move from one chromo- Genetically Modified Foods a risk-based system using the EU and somal location to another(Fedoroff The success of modern agricul- the United States as the respective 1989).The resulting effects on the ob- ture thus far can be rightfully attrib- standard bearers for these regulatory served phenotype of plants have been uted to plant breeding and the creation stances?(3)If the PP is strictly and/ well studied in conventional breed- of cultivars that perform very well in or loosely applied,will it affect the ing and do not differ in any biologi- the context of different environments. future adoption of the technology and cally meaningful way when specific Although inputs(fertilizer,pesticides, will there be lost benefits or negative transgenes are inserted(Bradford et 10 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY al.2005). differently than in Europe.A contrast harmful even without a scientifically Transfer of genes across species is between the regulatory approaches backed proof of hazards.Thus,the PP also a natural phenomenon. Bacteria of the two jurisdictions provides in- introduces the concept of uncertainty are able to transfer genes to unrelated struction about the contrasting ap- as a consideration when regulating bacterial species and,in some cases, proaches of the PP and risk assess- GMOs.The novelty and potential for plants via a mechanism known as ment.The United States has relied harm conceived for a comparatively horizontal gene transfer.Indeed both on the 1986 Coordinated Framework new technology first led to a morato- bacterial and viral gene sequences are for Regulating Biotechnology(OSTP rium on new approvals of genetically commonly detected in various con- 1986).In this framework,three engineered crops and foods and then, ventional plant cultivars(Bradford et agencies—the U.S.Department of following its end in 2004,a case-by- al.2005).Whether the inserted"new" Agriculture,specifically the Animal case,albeit slow,process of approval. DNA functions or not depends on the and Plant Health Inspection Service; European Union regulation of specific regions of a host organism's the Food and Drug Administration; GM crops is mandated in three dif- genome at which the complementary and the EPA—share primary respon- ferent interacting directives or regu- interactions occur.Most insertions sibility for regulating the introduc- lations: "Deliberate release into the will not be functional,but a small tion and assessing the safety of GMOs environment of genetically modified percentage will be transcribed and (McGinnis,Meyer,and Smith 2012; organisms"(Directive 2001/18/EC); expressed. McHughen and Smyth 2008).While "Genetically modified food and feed" This process of gene insertion and more specific regulations have been (Regulation 1829/2003);"Concerning the phenomenon of horizontal gene written over the last decade to en- the traceability and labeling of ge- flow have been noted to occur com- hance regulation,largely in response netically modified organisms,and the paratively frequently in nature and are to scientific scrutiny and public input, traceability of food and feed products now considered a contributing driv- new statutes were not created to deal produced from genetically modified er of evolution(Keeling and Palmer with agricultural biotechnology. organisms"(Regulation 1830/2003). 2008).So insertion of a new coding Although the reliance on exist- The latter two of these mention the sequence of DNA into a plant genome ing statutory authority under the requirement for a precautionary ap- using recombinant DNA technology is Coordinated Framework has result- proach but are written more as philo- not inherently new or as uncertain as ed in some gaps and overlaps in the sophical directives.The actual regu- the PP as applied supposes.Rather we oversight of GMOs(Mandel 2004), lations require a risk assessment,and have learned to speed up a naturally the Coordinated Framework has gen- the requirements for carrying out this occurring biochemical mechanism to erally worked fairly well to regulate mandate are detailed within the regu- more quickly and precisely breed new GMOs and there has been little pres- lations. In this sense,the European characters into plants and animals.To sure or need to try a different regula- laws are not unlike requirements in be sure,modern biotechnology per- tory approach(McHughen and Smyth the United States.The European laws mits the transfer of genetic informa- 2008;Pew Initiative on Food and require that the entity wishing to in- tion between different species in ways Biotechnology 2004).All of these troduce into the food chain or release that are unlikely to occur in nature, agencies have fulfilled their legislative into the environment take primary re- but any risks that result from such mandate under a risk assessment para- sponsibility to submit the data needed transfers will be due to the specific digm.While safety is ultimately the for risk assessment. construct created and the environment goal of regulatory action,a precau- The European regulations devel- into which it is released rather than to tionary approach is not stated explic- oped specifically for GM products and the simple fact that genetic recombi- itly,although some degree of precau- the U.S.Coordinated Framework,as nation and transfer was involved.The tion is inherently applied. well as specific responsibilities and focus of any precautionary regulatory In contrast to the U.S.regulatory jurisdiction of each federal agency approach should therefore be shifted system,the EU starts from a philo- as applied to GM products,do not from breeding mechanics to trait func- sophical premise of the PP.In part, differ in the essential need for some tionality in the context of its environ- this approach to managing risk is form of premarket risk assessment. ment and use. consistent with principles of precau- Necessary risk management follows tion mapped out in the Cartagena from the findings of the risk assess- Contrasting Regulations in the Protocol on Biosafety(Convention on ment.The PP comes into play with United States and the European Biological Diversity 2000).Most PP the EU regulations in the mandate for Union proponents identify the central core of GM product traceability and labeling In the United States,new crop the principle to be that a technology (medicines exempted)and the require- cultivars produced using DNA re- should be prevented from commer- ment for postmarketing surveillance combinant technology are regulated cialization if it is suspected of being (Heinemann and Ell-Kawy 2012). In COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY i the United States,however,registrants processed with U.S.corn had detect- Qiam 2009; Raney 2006).How much of GM crops containing gene cod- able GM traits(Kim et al.2010),sug- gross margins benefit,however,is ing for plant-incorporated protectants gesting that nearly ubiquitous use of likely to be related to their home (PIPs)are required under FIFRA sec- GM corn and soy in the United States country.For example,the benefits of tion 6(a)(2)to submit adverse effects does not mean that all processed growing Bt(Bacillus thuringiensis) information regarding their products. foods would exceed the EU's labeling cotton are much higher in India than This regulatory requirement suggests threshold.Considering that most GM in China,but for all countries pesti- that postmarket monitoring also has crops are grains and few are directly cide costs are lower with the adop- been built into U.S.regulations for at consumed but rather dispersed,dilut- tion of GM technology(Finger et al. least some GM crops when they con- ed,and/or degraded during food pro- 2011).Evidence of foregone loss of tain PIPs. cessing,the EU's application of the PP income from increased input costs to The EU expressly relies on the PP to require mandatory traceability and farmers owing to the restrictive regu- to require traceability and labeling of labeling of GM foods may not neces- latory policies of the EU was estimat- GM foods(Regulation 1830/2003, sarily result in appreciable differences ed to range up to$1.2 billion per year preamble [31),which is perhaps the in exposures to GM food ingredients. (Park et al.2011). most distinguishing feature of the EU The role of PP advocates who GM regulations compared to the re- Adoption of Genetically Modified deem genetically engineered plants quirements of U.S.law.The EU trace- Technology and Potential for Lost too hazardous and uncertain has es- ability and labeling regulation is not Benefits sentially killed or at least seriously absolute,however,notwithstanding delayed introduction of Bt brinjal its precautionary justification,because Shortly after the United States (also known as eggplant) into Indian it does not require labeling for foods commercialized GM crops,efforts agriculture(Kathage and Qaim 2012; to export them to Europe faced se- containing GM ingredients below the Padmanaban 2009).This crop is regulatory threshold of 0.9%presence vere opposition,leading to a de facto widely consumed and reputed to have of inadvertent authorized GM ingre- moratorium that was not lifted until medicinal properties.It is,however, dients in any food or feed that would 2004.Arguably,this moratorium rep- quite vulnerable to insect damage. trigger mandatory labeling. resents application of the strong PP, A Bt variety was developed in an i.e.,rejection of a technology when Ironically,the perception of a definitive proof of safety is absent(a Indian company that had partnered more precautious system that requires standard few,if any,technologies or with Monsanto.Field trials indicated traceability and labeling has not pre- steep reductions in insecticide use. products could satisfy).If the PP is vented exposure of many European Estimated economic returns were consumers to GM foods.For exam- applied to reject GM foods more gen- hundreds of dollars per acre(Shelton ple,one study of putatively GM-free erally,one could speculate on what 2010).The Genetic Engineering foods showed that 40%of sampled benefits might be lost,especially if Approval Committee of India had ap- items contained detectable levels of the technology is reasonably certain r its commercialization after GM soy,albeit below the 0.9% EU to pose no harm(an often-used U.S. proved edd testing confirmed that it met threshold that would trigger labeling regulatory standard).Three cases dis- safety standards.Following a coor- (Partridge and Murphy 2004).A study cussed later are: (1)how the PP could dinated effort by NGOs to invoke of German processed foods showed affect benefits accrued by growers and the extreme version of the PP,how- extending 75%of GM soy detections were extending to those in rural areas;(2) ever,the Minister of Environment less than the mandatory labeling how the PP could affect future devel- and Forests banned cultivation.Thus, op threshold(Greiner,Konietzny,and ent of nonproprietary crop seed the Bt brinjal case is but one glaring dev Villavicencio 2005).Thus,European development;and (3) how the PP can example of how advocacy groups, consumers are exposed to GM foods impact health improvement by slow- under cover of the PP,can influence if one considers the possibility that ing a decentralized solution. government policy against a technol- many foods originating from GM ogy that poses no problems for human crops may fall below the labeling Benefits to Farmers and Their consumption or the environment when threshold. Communities appropriately scrutinized using risk On the other hand,lack of label- Enough time has passed since the assessment. ing in the United States does not nec- introduction of GM crops for mea- essarily mean that U.S.consumers surement in economic trends around are exposed to higher levels of GM the world.Studies suggest that,more Introduction of New Nonproprietary crop-derived foods than European often than not,yields are greater when Genetically Modified Traits residents.For example,a study using GM crops are compared to conven- Ironically,advocates of a strict an analytical detection limit of 0.5% tional cultivars and gross margins precautionary approach in lieu reported that<30%of sampled foods of return are better(Carpenter 2010; of product(i.e.,phenotype)risk 12 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 1 assessment have strengthened the policy toward a proliferation of tests than good to human health and the hand of proprietary GM seed holders. that perhaps seem unnecessary.The environment(Goklany 2001). The extra layers of regulation for a case of golden rice has become the well-understood plant breeding meth- poster child for a technology designed The Global Spread of Genetically od have led to a situation in which to help nutrient-deficient populations Modified Organisms universities or other nonprofit entities gain adequate nutrients from their The global spread of GM crops cannot afford to bring their nonpro- own food supply that has been de- proves a very rapid expansive adop- prietary cultivars to commercial status layed by opponents relying on the PP. tion of the technology in many coun- 1 (Lotter 2009).Holders of proprietary Specifically,golden rice is a tries beyond the United States(Khush seeds with substantial commercial po- popularized name for a rice cultivar 2012).The 2011 data show produc- 1 tential are essentially the only entities that has been transformed by genetic tion of these crops on nearly 420 mil- that can afford the myriad of regula- modification with two genes that al- lion acres among 30 countries(James 1 lions.Such is the result of the precau- low the seed endosperm to synthe- 2012).The numbers themselves speak tionary focus on the process of plant size carotenoids(Beyer et al.2002). to a global farmer population wanting breeding rather than the product.Yet, Present rice cultivars lack sufficient new technologies that are perceived to when considering developing coun- enzymatic activity to carry out this benefit them. tries and populations in poverty,an synthesis.Carotenoids are microbially Thus,with or without atten- i urgent need exists to either develop a transformed by human gut microbiota tion to the PP,the technology has, "homegrown"seed industry and GM to vitamin A.A significant population and is likely to continue to,spread. I crop technology or perform greater of children is deficient in vitamin A Nevertheless,because nongovern- public research on plant varieties that and does not have access to the typical mental advocacy organizations have will provide food security and speed remedies available in the economical- gained voice and have proven to wield economic development(Pingali and ly developed countries,such as more significant influence on governmental Traxler 2002; Spielman 2007). leafy green vegetables like spinach, policy(Falkner 2007;Seifert 2011), In addition to nutritional attributes, carotenoid-rich root crops like carrots, these forces will continue to demand much nonprofit research is focused on or vitamin supplements. that the PP be implemented.If govern- improved biofuel crops and processes The slow,drawn-out regulatory ments do not themselves restrict GM as well as crops that can withstand morass holding up dissemination of products directly based on the PP,the drought and temperature extremes golden rice varieties,despite numer- experience in Europe of NGO advo- (Vinocur and Altman 2005;Wang, ous studies vouching for its safety,is cacy groups directly pressuring retail- Vinocur,and Altman 2003).Indeed, partly due to regulatory requirements ers to not carry GM-labeled products the latter traits are conferred at one (Potrykus 2010).The initial and ongo- on their shelves will also continue to time by simple gene insertion,and the ing strong push against the cultivar exert scientifically unjustified nega- cultivars are already developed.They from advocacy groups based on the tive pressure against biotechnology- still,however,have not been commer- PP,however,has also arguably con- derived crops. cialized several years after their re- tributed to the lack of introduction at ported development and functionality this time. Food Irradiation testing owing to prohibitive regulatory In addition to golden rice,con- Access to sufficient,safe,and costs(Wang and Brummer 2012). cerns have been expressed that the nutritious food is central to the con- introduction of needed nutritionally improved cassava will be slowed cept of food security(CFS 2012). Introduction of Traits Beneficial to Ionizing radiation that is used as a Consumers (Adenle et al.2012).The recalcitrance of some advocacy groups to accept food-processing technology has two Biofortification of foods,defined the process of genetic engineering benefits that could contribute substan- simply as production of cultivars with despite repeated safety testing shows tially to food security: the destruction enhanced nutrient content,has long the flaw of a regulatory policy that fo- of certain foodborne pathogens,thus been a goal for plant breeders(Khush cuses on process(the PP) rather than making the food safer;and prolonga- et tion of the shelf life of food b et al.2012).Presently,research and product(typical risk assessment and y killing development of such cultivars seems management paradigm).Moreover, pests and delaying the deterioration more prevalent in public institutions the selective application of precaution process,thus increasing food supply. than in private industry. Despite suc- Independent studies spanning decades under the PP to look only at the poten- have consistently shown ionizing cessful progress,commercialization tial risks presented by a new technolo- y g ra- of seed with value-added traits for gy while not also looking at the exist- diation to be an effective,safe,and nutrition enhancement seems mired ing risks lessened by that technology, feasible technology for food process- in the advocacy of precautionary re- skews risk decision making and may ing,but precautionary perceptions sistance that has forced regulatory result in decisions that do more harm and policies have severely limited the COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 1:3 IIMIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIMIIIIIIIIIIIIIIIIIIMI contribution this technology can make Atomic Energy Agency)/WHO corn- of irradiated food without any sig- to food security. mittee of experts found that irradi- nificant evidence to the contrary. Ionizing radiation occurs naturally ated foods are safe and wholesome Regulatory authorities in many coun- in the environment and may also be after reviewing extensive chemistry tries nevertheless continue to be re- artificially produced using x-ray tubes, and animal-feeding studies from sev- luctant to create a regulatory environ- electron beam accelerators,or gamma eral independent laboratories(WHO ment that would facilitate the broader sources such as cobalt-60.Exposing 1981).The committee concluded that use of food irradiation and enhance food to high doses(greater than 20 no special nutritional or microbio- its contribution to food security now kilograys IkGysl)of ionizing radia- logical problems were associated with and in the future.For example,since tion can destroy harmful microorgan- the irradiation of any food commod- 1999 the EU only has allowed for the isms such as E.coli and Salmonella. ity with an overall average dose of treatment of dried aromatic herbs, This makes irradiation an important up to 10 kGy.In 1992,the WHO is- spices,and vegetable seasonings(EC strategy for decreasing foodborne ill- sued a policy statement reaffirming 1999).Adding authorizations,includ- ness and waste. Low-dose treatments that"Ii]rradiated food produced un- ing grandfathering authorizations that (below 1 kGy)effectively inhibit der established Good Manufacturing existed previously in the EU,requires sprouting(e.g.,potato,onion,gar- Practices is to be considered safe and that member states submit a petition to lic)and can also increase the shelf nutritionally adequate"(WHO 1994). the European Food Safety Authority life of many fresh commodities by In 2003,the Codex Alimentarius stan- with individual studies on the toxicol- delaying ripening,improving quality dard was revised to indicate that the ogy of each food and for each of the factors such as juice yield and hydra- maximum absorbed dose could exceed proposed dose ranges requested. tion,and killing or sterilizing inva- 10 kGy when necessary to achieve An item-by-item,dose-by-dose sive insects such as fruit flies (Urbain a legitimate technological purpose toxicological review,followed by an 1986).All foods are not suitable for (Codex Alimentarius Commission extended political approval process, treatment with ionizing radiation,just 1983). is difficult to justify in the face of a as all foods are not suitable for can- The American Medical plethora of scientific findings and in- ning,freezing,drying,and other food- Association endorses food irradia- ternationally agreed policies regard- processing technologies. Lion as"a safe and effective pro- ing the safety of food irradiation and Food irradiation is sometimes re- cess that increases the safety of food the lack of contradictory evidence that ferred to as"cold pasteurization" be- when applied according to govern- would argue for greater uncertainty. cause the effect of irradiation is simi- ing regulations"(Marsden 1994). Such cumbersome bureaucratic re- lar to pasteurization without heating An E.coli 01.57:H7 Consensus quirements and strict controls severely the product or significantly changing Development Conference sponsored stifle implementation of the technol- its physical or sensory characteristics. by the American Gastroenterological ogy under the auspices of demonstrat- Contrary to many popular percep- Association Foundation conclud- ing precaution in matters of consumer Lions,irradiated food does not become ed that"jpirotection of the public's safety where large amounts of sound. radioactive.In the same way that a health requires the immediate imple- consistent scientific findings sup- microwave oven does not make food mentation of currently recognized sci- ported by international consensus are radioactive,the energy from ioniz- entific technology for ensuring food politically inadequate to offset real or ing radiation is not retained in treat- safety.An emphasis should be placed imagined uncertainties. ed food.Ionizing radiation only has on science-based monitoring and veri- Part of the problem is the general sufficient energy to remove electrons fication of the nation's slaughter plant perception that nuclear technologies from atoms,creating short-lived ions operations.The current inspection- are intrinsically dangerous and that (free radicals)that damage the cells of based system should be replaced by a the consequences of miscalculations contaminating organisms.The forma- science-based risk assessment pro- are catastrophic.Another problem is tion of free radicals and any resulting cess with government verification." that,based on the declaration made radiolytic products raises concerns The conference recommended that by the Joint FAO/IAEA/WHO Expert about possible health hazards,even "Ii Irradiation pasteurization is a safe Committee on Food Irradiation in though free radicals are also formed and effective intervention strategy, Rome in 1964,irradiation was defined in much higher concentrations when especially in ground beef and should as an additive rather than a process food is barbequed,fried,or baked and be implemented as soon as possible" (WHO 1966).These issues contribute they disappear within a fraction of a (Gallager and Kwittken 1994). to regulatory foot dragging by casting second(Taub 1984). Numerous other studies spanning a negative light on the public percep- In 1981,a joint FAO(Food and more than four decades have resulted Lion of food irradiation,even though Agriculture Organization of the in similar conclusions regarding the other consumer products,ranging United Nations)/IAEA(International efficacy,safety,and wholesomeness from bandages to medical instruments 4 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY L to tampons,are irradiated in the same ation is the lack of clarity regarding fensible basis for risk management way and have no such stigma attached the type,quantity,and quality of evi- decisions.As the record and case stud- to them. dence(scientific or otherwise)that is ies summarized earlier demonstrate, Opponents of food irradiation say required to overcome the uncertainties the PP is flawed.Without a workable the preferred alternative is increased that are the causes for concern with definition and agreed-upon criteria for government regulation and inspection; food irradiation.In other words,an its application,the PP's employment however,inspectors cannot see harm- arbitrary and nontransparent threshold to date,including in the food context, ful microorganisms and it is not cur- for reasonable certainty has been es- has been dictated more by political rently feasible to perform routine lab- tablished by adopting a precautionary influences than scientific factors.For oratory analysis on huge commercial approach.The problem is compound- example,governments have exploited quantities of raw products(Fumento ed if a judgment regarding the degree the PP's ambiguity and arbitrariness to 1994).An argument frequently raised of uncertainty becomes the basis for adopt protectionist policies,and activ- by critics is that the technology ben- not doing a risk assessment.Any cred- ist groups have used the PP to apply efits sellers,not producers,because ible scientist will agree that uncer- a double standard of higher scrutiny inferior quality products can be safely tainty is ubiquitous.Uncertainty may and demands for certain technologies marketed.The same could be argued be associated with error or variabil- of which they disapprove.Moreover, for any other form of food processing, ity,and usually both—but it is always in many cases the PP has been applied but by focusing this argument on food present at some level.The challenge or proposed to be applied in ways that irradiation,such claims contribute to in risk assessment is recognizing and may have the net effect of increas- greater doubt in the minds of regula- characterizing the uncertainty.The ing overall health and environmental tors and the general public regarding absence of such an analysis makes it risks by impeding safety-enhancing the wisdom of endorsing and applying impossible to understand a strategy technologies.Given these failures,it food irradiation as part of a broader for mitigating uncertainty. is not surprising that the momentum strategy to promote food security ei- The challenge for risk managers is behind the PP is fading,and it has ther locally or globally. responding appropriately to risk,rec- become clear that the PP will never A precautionary approach to man- ognizing that zero risk does not exist. achieve the consensus that its propo- aging the risks associated with food A precautionary approach is one type nents had once envisioned. irradiation sends a signal that food of response to risk that,by virtue of The failure and decline of the PP processed with this technology is its reflection in decision making,sets does not mean that appropriate risk more dangerous,and food security, a bar for research that becomes an un- management is not essential.It is in trade,and other benefits that may be justified barrier if it is not transparent the joint interests of government,in- derived from using the technology do and based on rational criteria.A centu- dustry,NGOs,and the general public not outweigh the risks.This is a clas- ry ago,the pasteurization of milk was to ensure appropriate risk manage- sic example of an important weakness banned from commercial use because ment is applied with all technologies in the PP—the assumption that acting of irrational fears.Today,most con- to minimize unreasonable risks and to protect cannot result in damage. sumers would consider unpasteurized injury.The PP can be credited for In the case of food irradiation,the milk to be the greater risk.The same bringing attention to the need to bet- barriers to implementation that auspi- transition has yet to occur with food ter define the appropriate level and 1 ciously serve to protect public health irradiation. form of risk management that should limit the use of the technology not be applied in various situations.To only to protect public health,but also SUMMARY AND CONCLUSION date,however,the PP's solution to the to provide broader benefits associ- question of appropriate risk manage- ated with food security and trade.It is, An empirical analysis of the PP ment is blunderbuss rather than nu- therefore,a simple question not only in practice concluded that the"pre- anced,extreme rather than reasoned, of protection that is gained but also of cautionary principle may well be the biased rather than balanced,and ar- protection that is lost,other benefits most innovative,pervasive,and sig- bitrary rather than principled.Its fail- that will be lost,and the repercussions nificant new concept in environmental ure to offer a credible and reasoned of both scenarios.Because there are policy over the past quarter century. framework for the application of risk risks from using the technology and It may also be the most reckless,arbi- management suggests that the PP will also risks from not using it,precaution trary,and ill-advised"(Marchant and be increasingly controversial,margin- cannot be increased on one side of the Mossman 2004).Notwithstanding its alized,and ignored in the future. question without decreasing itself on swift rise in the international arena, Where should we go from here? the other.This nonsensical argument the PP has serious shortcomings and After twenty years of being at the points to a fundamental flaw in the PP. does not,at least in its current form, forefront of the debate on risk man- A further weakness in this situ- provide a coherent,rational,and de- agement,there has not been any COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 15 progress on further refining and opera- PP helps us to more consciously strive formal and explicit application of tionalizing the PP to provide a sen- for such a deliberate and balanced ap- precaution in regulatory decisions. sible,predictable,and reasonable de- proach to precaution,that might be its Risk assessment.The estimation and cision rule.Some individual scholars most positive legacy. characterization of a risk,often have put forward promising proposals But for the millions of people quantified. to better rationalize and structure the who are lacking adequate nutrition to- Risk management.A policy decision PP(e.g.,Farrow 2004;Goklany 2001; day,and the many millions more who on what to do about a risk. Sandin and Hansson 2002),but these will suffer as a result of the grow- Transgenic engineering.The specific proposals have received no politi- ing food demand-supply gap pro- transfer of a gene from one species cal traction.It is becoming increas- jected over the next few decades,the into another species accompanied ingly apparent that the PP is not going PP does more harm than good.New by stable expression. to be better defined and operational- technologies of many different types ized because it cannot be—there is no that can produce safer,more abun- Transposon.A transposable element consensus even among the proponents dant foods,and wider distribution containing genetic material con- of the PP as to what it should mean of those technologies,are crucial to trolling functions other than those or require.Two PP supporters recog- decreasing the number of hungry and related to its relocation. nized that the PP may be too amor- under-nourished people in the world Yield gap.The gap between the aver- phous to be captured by definitions or now and in the future.The evidence age and potential crop yield. operational criteria,noting that"the summarized in this Issue Paper has application of precaution will remain demonstrated that the PP holds back LITERATURE CITED politically potent so long as it contin- technology,innovation,incomes, ues to be tantalizingly ill-defined and environmental improvements,and Adenle.A.A..O.C.Aworh.R.Akromah.and imperfectly translatable into codes of health benefits,while increasing trade G.Parayil.2012.Developing GM super conduct,while capturing the emotions disruptions,risks,and human suffer- cassava for improved health and food of misgiving and guilt"(Jordan and ing.The PP has been tried but has security:Future challenges in Africa.Agr O'Riordan 1999). failed as a risk management strategy. 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(:AST is u nonprofit rv�;aniOJnan e,,s 1'.,se.i „/ o t,a+v/r( "rereti,,, 'old ',cane in,iaJuai, 'indent. company, nnrynr,lit, and er,sorrate so.dets rumbas,. CAD's Board r.k .:ornp„sed o/ representatives of the scientific sn'aett s. conrinercml companies, nonprofit or trade ar,gani.:altans, and a 8,0'trd of Directors. (.'AST was established to l`r72 ui 0 reknit J/ ,t meeting.sponsored to 1°'(1 by r/re•V,rtional.1c'adent}'of National Research Conned. ISSN 107040021 Additional copies Of this Issue Paper are available from CAST.Carol G.tele.;tf(tuattins;Scientific Editor,http:i'Hh'H'.cast-science.or{. Citation: Council for Agricultural Science and Technology(CAST).2013.Impact of the Precautionary Principle on Feeding Current and Future Generations. Issue Paper 52.CAST.Ames,Iowa. CAST' The Science Source for Food, Agricultural,and Environmental Issues 4420 West Lincoln Way Ames,Iowa 50014-3447,USA (515)292-2125,Fax:(515)292-4512 E-mail:cast@cast-science.org Web:www.cast-science.org 20 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY TO: Brenda Ford, Council Council Chair, Committee on Public Safety & Mass Transit Margaret Wille, Vice Chair, Committee on Public Safety & Mass Transit Karen Eoff, Member Greggor Ilagan, Member Dru Mamo Kanuha, Member Zendo Kern, Member Dennis "Fresh" Onishi, Member Valerie T. Poindexter, Member J. Yoshimoto, Member FROM: Susan C. Miyasaka, Ph.D. SUBJECT: Testimony against County Council Bill No. 109 My name is Dr. Susan C. Miyasaka, and I am an Agronomist at the University of Hawaii. I am Y Y � g Y providing testimony to you as a private individual and not as a representative of the College of Tropical Agriculture and Human Resources (CTAHR). My testimony is not biased by financial interests, because I have not received any research funding from any of the seed companies. County Council Bill 109 makes it"unlawful for any person to cultivate, develop, or use any genetically modified organism..." It exempts state or federally licensed medical or agricultural research institutions to conduct licensed medical or agricultural research or production involving genetically modified organisms, provided all activity relating to genetically modified organisms is located in a biosafety level 3 containment facility..." Persons engaged in the cultivation, development or use of genetically modified organisms prior to the effective date of this article may continue such cultivation, development, or use for a period not to exceed thirty months after the effective date of this article...." This bill only focuses on the "adverse effects of biotechnical modification of any organism's genome." What about the potential benefits of genetically engineered (GE) crops? Potential Benefits of Genetic Engineering of Crops: There are many positive benefits of transgenic crops that are being developed or are in existence, such as disease or pest resistance, drought resistance, increased yield, and improved nutrition. I strongly encourage you to educate yourself further about the potential benefits of genetic engineering of crops. Mark Lynas, former anti-GMO activist, is now apologizing and saying that genetic engineering technology is science- based, safe for consumers, and needed to feed the world population and protect the environment. Watch the video of his speech at the Oxford Farming Conference held 3 January 2013: http://w∎vw.mark lvnas.org 12013/01/lecture-to-ox lord-farm ing-conference_3_t.inuary-2013/ Now, let's examine whether this bill is needed to protect human life from the adverse effects of biotechnological modification of any organism's genome". (1) Claims of Harm to Human life: The national and international scientific communities are in agreement that GE crops approved by the U.S. Department of Agriculture, Environmental Protection Agency, and the Food and Drug Administration are as safe for human or animal consumption as non-GE crops and foods. The American Medical Association's Council on Science and Public Health reported (2012) reported that"Bioengineered foods have been consumed for close to 20 years, and during that time, no overt consequences on human health have been reported and/or substantiated in the peer-reviewed literature." "The American Association for the Advancement of Science, the World Health Organization and the exceptionally vigilant European Union agree that GMOs are just as safe as other foods" (Scientific American, 2013). The official position of the American Dietetic Association (2006) is that"Agricultural and food biotechnology can enhance the quality, safety, nutritional value, and variety of food available for human consumption, and increase the efficiency of food production, food processing, and food distribution, and environmental and waste management." (2) Claims of preserving the biodiversity of plants, animals, and other organisms on the Island of Hawaii. Presumably, it is suggested here is that GE crops will cross-pollinate and "contaminate" heritage crops. First, Hawai'i is a source of biodiversity for native (or endemic) plants, animals, and other organisms. Our Island is not a source of biodiversity for agricultural crops that ancient Polynesians brought here. In fact, biodiversity is very low for indigenous food crops, such as taro, banana, and breadfruit, because only a few varieties could be carried here in canoes. To my knowledge,the only native plant species that could be at risk of cross-pollination with a GE crop is a native species of cotton. As a result, the seed companies do not conduct transgenic research on cotton in Hawaii. If the County Council truly wishes to preserve the biodiversity of native plants in Hawaii, they should focus on: (a) limiting the importation of invasive weeds, pests, and diseases into Hawaii; (b) utilizing bio-control to control existing weeds and pests; and (c) controlling the spread of invasive plants, insects, and animals into native forests through funding of organizations responsible for these tasks. (3) Claims of Harm to Honeybees: Concern is expressed in this bill about transgenic pollen containing pesticides; however, bee populations on this Island are being harmed primarily by varroa mites and small hive beetles, and NOT by transgenic pollen. Sudden colony collapse of honeybees is occurring in many European countries where GE crops are not grown. The European Union has placed a two year ban on nicotine-like pesticides (neonicotinoids). If the County Council truly wishes to improve the health of honeybees on the Big Island, they should focus instead on: (a) limiting the importation of invasive pests that harm honeybees into Hawaii; and (b) funding research on best ways to control existing pests of honeybees, such as varroa mite and small hive beetles. Is this Bill Enforceable?: According to this bill, the director of the department of environmental management is responsible for determining whether"there exists a violation of any provision of this article..." I question whether this bill is enforceable: Does the director have the ability and resources to determine whether a farmer or rancher is breaking the law by growing transgenic crops? Will this bill result in a witch hunt with people complaining about their unliked neighbors? Who has the expertise within the County of Hawaii to determine whether a crop is transgenic? Who will be responsible for extracting DNA from the suspected transgenic crops? What laboratory will perform the DNA analysis to determine whether the crops are transgenic and how long is their turn-around time? Is this the best use of County resources? Task Force or Ad-hoc Committee on Agricultural Sustainability and Co-Existence. Please form a Task Force or Ad-hoc Committee of farmers, ranchers, and scientists to discuss agricultural sustainability and co-existence of all types of farming systems. There is no scientific reason that co-existence cannot happen between organic and conventional farmers. We live among one of the most cultural diverse populations in the world, and we can serve as a model for how agricultural sustainability and co-existence can and should happen. Please vote `NO' on Bill 113. Instead, please form a Task Force or Ad-hoc Committee to make recommendations about Agricultural Sustainability and Co-existence of organic and conventional farmers on the Big Island. References: American Dietetic Assoc. 2006. Position of the American Dietetic Association: Agricultural and food biotechnology. Vol. 106, pg. 285-293. http://w .ncbi.nlm.nih.gov/pubmed/16442880 AMA (American Medical Association). 2012. Report of the Council on Science and Public 1 Health. CSAPH Report 2-A-12. http://www.ama-assn.org/resources/doc/csaph/aI2-csaph2- bioengineeredtoods.pdf Scientific American, The Editors. 2013. Labels for GMO Foods are a Bad Idea. Sept. 6, 2013. http://www.scientificarnerican.com/article.cfiri?id=labels-for-gmo-foods-are-a-bad-idea