She felt terrible, with a horrible pain in her gut that cut like a knife, and nausea and fever to match. Usually stoic in the face of pain, my daughter was doubled over and gasping.

When we took her to the hospital, the doctor took one look at her and immediately ordered a scan. Within hours she was in the operating room to have her ruptured appendix removed.  After the operation, the surgeon showed us pictures of the process, including a glossy photo of the inflamed appendix and the staple he had used to close off the end from which it had been removed.  Almost immediately after surgery, my daughter’s fever diminished. Her post-surgical pain was minimal compared to the searing pain that brought us to the hospital in the first place. As I write this, she is still in the hospital where she will remain for a few more days. But the crisis is over and there is improvement by the hour. By the time you read this, she will probably be home again in her own bed.

In the May 2009 issue of Bioethics in Brief, I discussed the fear of novelty that often leads to skepticism about new technology. I urged that moderate skepticism may be appropriate if it leads us to logically weigh the risks involved in new technologies, and that caution may be appropriate when we are unsure how to evaluate the risks we face.

The other side of this equation, of course, is the benefit that technological advances bring. In my grandparents’ generation, people often died from a ruptured appendix, and surgery was a far less certain undertaking.  Today, an appendectomy is a relatively minor procedure. When the surgery is uncomplicated, patients may leave the hospital within a day or so of surgery.

We are grateful for life-saving technologies when we experience their benefits firsthand, and people are typically much less wary of technology—including biotechnology—when their most central interests hang in the balance.

The danger of adopting a technology that is unproven is the difficulty in weighing the involved risks.  Since it is not possible to predict every eventuality, we may not understand how to weigh the risk until it’s too late.  But the alternative danger— the danger involved if new technologies are not adopted—may also involve serious risks. We may not give proper weight to those risks until we experience the benefits first hand. Today as I write this, I am vividly aware of the benefits associated with the surgical technologies that saved my child’s life.

Precautionary Principles

How should we evaluate unproven technologies?  It is sometimes recommended that we adopt a precautionary approach.  The precautionary principle offers a general recommendation that we should be cautious when risks are unknown.  Those who dislike the principle often recommend it as a general, blanket condemnation of any new technology simply on the basis of its novelty.  In a 2003 New York Times editorial, Clyde Prestowitz memorably represented the precautionary principle as a recommendation that “If we can’t prove absolutely that [a new technology] is harmless, let’s ban it.” (Prestowitz, 2003)  Stated in this way, the principle becomes an unfortunate decision criterion.  It is neverpossible to prove absolutely that a novel technology is harmless.  If we are entirely ruled by our fears we will miss the benefits that new technologies offer.

Often, these benefits can be measured in the same terms of life and death, happiness and misery that we may use to weigh risks and costs. Prestowitz is not a fan of the precautionary principle, so his statement of it is intended to make the principle appear ridiculous. While this may make a successful rhetorical point, his argument would have been more interesting and significant if he had re-presented the principle.

A more moderate version of the precautionary principle found its way into international law in the 1992 Rio Declaration. That agreement states “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”  (Rio Declaration, 1992, Article 15) If Prestowitz’s statement of a precautionary principle is absurdly strong, so that it would prevent acceptance of any new technology, then perhaps the Rio statement is absurdly weak.  Of course “lack of full scientific certainty” should not constitute a reason to postpone “cost effective measures” to prevent harm (or degradation).  Empirical science never provides certainty.  While one precautionary statement seems to rule out acceptance of any technology at all, the Rio statement is too weak to motivate caution even in cases where caution would be fully justified.

Confusion about the precautionary principle has resulted in the existence of opposing rhetorical camps.  Some people reject the principle as obviously excessive while others extol it as a minimal and obviously justified principle for policy choice.  If those involved in this discussion have different principles in mind, they may both be correct.  But they are talking past each other.

Risky Decisions and New Technologies

I am overwhelmingly grateful to the people who developed and employed the surgical procedures that saved my daughter’s life recently. But the first time these procedures were used, the risks involved were unknown, and there must have been a reasonable expectation that they could fail.  In the case of a ruptured appendix, the expected cost of doing nothing is high.  Left to follow its natural course untreated, a ruptured appendix can be expected to lead to pain and death.  In some cases, new technologies leave us with less dire alternatives than this.  The cost of caution is often (though perhaps not always) less immediate and extreme for technologies in agricultural biotechnology.

The question whether we should chose to err on the side of caution or optimism will not be solved by reference to either of the simple principles articulated above.  We need rationally to consider all of the risks involved in our choices, including the opportunity cost of proceeding with an abundance of caution.  These costs are difficult to measure, since they are reflected in the foregone benefits that technologies might have brought.  To see that these costs are very real, we would do well to consider the loss we would have experienced if past technologies had not been developed.  In some cases, these opportunity costs are reflected in the lives of people who might have been positively affected by the adaptation of the new technology, even to the extent of dramatically extending the lengths of their lives.

References

Gardiner, S. 2006.  A Core Precautionary Principle. J. Pol.Phil. 14(1):33-60.

Prestowitz, Clyde. 2003. Don’t Pester Europe on Genetically Modified Food. New York Times, January 25.

Stich, S. 1978. The Recombinant DNA Debate. Philosophy and Public Affairs. 7(3) Spring 78, pp. 187-205.

Clark Wolf is the Director of Bioethics and a Professor in the Department of Philosophy at Iowa State University. He is a faculty member in the Graduate Program in Sustainable Agriculture and has a cortursey appointment in the Department of Political Science. He teaches and co-teaches a variety of courses, including Foundations of Sustainable Agriculture, Environmental Ethics, and Bioethics and Biotechnology. Clark gives and organizes thought-provoking talks to diverse audiences at Iowa State, including talks on biotechnology and intellectual property.*

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the ISU Office of Biotechnology or Iowa State University.

Wolf, Clark. Precautionary Principles and the Cost of Caution. Bioethics in Brief, a Publication of the Iowa State University Office of Biotechnology. May 2010. Volume 12, Number 2.

* Biography composed by Anastasia Bodnar.

Over the last 15 years, agriculture has been changing technologically at an amazing pace. It is something that is truly fun to look back at and realize where we have come. As a producer of corn, soybeans, wheat, seed corn, and popcorn over many of those years it has truly changed what we are able to do and what we will be able to do in the future.

Equipment technology has created a way for us to be able to be better stewards of our ground and resources. Biotechnology has allowed us to push the food, feed, and fuel production to levels that only a few short years ago, many people would not have thought possible. Plus, we are utilizing fertilizer at a better rate. We are reducing our need for irrigation, in irrigated crop production. We are using fewer and fewer pesticides, which not only allows for a healthier product but also for cleaner natural resources like streams and drinking water.

For the farmer, this new wave of biotechnology, has allowed him to plant sooner and get over more acres faster. It also allows for a crop that can remain in the field in good condition longer. It is also allowing for new “green” technologies to come along with the feedstocks from the field being used for future cellulosic ethanol production and for helping coal fired electric plants to create a cleaner energy as well. All this is possible because of the healthy plants that biotechnology is allowing us to have. A plant that can protect itself, will be stronger then the plant that isn’t. Whether that protection is from in field pests or whether that is from the plant being able to be resistant to certain herbicides, it all helps in the final standability and yieldability of the crop that is planted.

Farmers love to plant biotech corn and soybeans. According to the USDA June 2009 Acreage report, US farmers planted 85% of their corn to biotech hybrids which was up from 80% in 2008. They also planted 91% of their soybean acres to biotech which was down 1% from 2008. Farmers have seen the value of these crops and are willing to plant them.

This doesn’t mean there doesn’t need to be more work done. Seed companies are going to have to realize that even though farmers are willing to plant biotech hybrids and varieties, they will start decreasing biotech acres, especially in “multi-stacked traits”, if they do not maintain an acceptable final yield. At the end of the day, farmers want yield. It is the final measuring stick of what the year was like.

As we move forward, we will need to find the way to feed an ever growing world. With population projections of 9 billion by 2030-2050, biotechnology is going to have to be the key to making sure the world has a plentiful, healthy, affordable food supply. And we, as farmers, will continue to plant it.

Brandon Hunnicutt farms in South Central Nebraska with his dad, brother, and cousin. They raise corn, soybeans and popcorn.  All their corn and soybeans contain some aspect of biotechnology in them, except for the popcorn.  Brandon has been involved with defending biotechnology and promoting throughout the years and currently serves as President of the Nebraska Corn Growers Association.

Before Thanksgiving break, my plant systematics professor told us that if we handed her a list of the scientific names of every plant species we consumed over the holidays we would get extra credit. I toyed with the idea of simply rewriting a recipe to include the latin names but considered that too easy. Instead, I’d have to go all out and write a full-on academic paper of my holiday experience. Since this would also be my first Thanksgiving away from home, I had cause to experiment. What follows, then, is my extra credit assignment:

Thanksgiving celebrations traditionally involve the ceremonial consumption of a flightless avian species, Meleagris gallopavo. Prepared as the centerpiece of an intricate meal that may also include Ipomoea batatas, Cucurbita pepo, Brassica rapa, etc., Meleagris gallopavo is widely perceived as an indispensable component of the holiday’s festivities. Presented here is the first report of a successful Thanksgiving feast lacking Meleagris gallopavo.

Full text here (pdf).

Cody Cobb is a first year Ph.D. student in plant biology & pathology at Rutgers, the State University of New Jersey. He has lived his entire life previous to this point in Texas and is currently enjoying his first autumn. He feels he should mention that his earliest desktop PC was an Acer. So is his ‘mustache.’

Consumer advocacy groups are a strange animal. It seems that for every influential lobbying group with a senator’s ear, there are hundreds or thousands with only vague mission statements and no clear agenda for attaining their stated goals. I once spent a summer working for the latter type. A hallmark of this kind of crew is the use of the petition (bonus points if it’s online and has been circulating for more than a year). Issue-specific petitions almost never work when directed at agencies; they are often unsophisticated (in a legal sense) and rife with ambiguous language and emotional rhetoric. If I were more cynical, I might point out the possibility that many people in charge of these groups are aware of their petitions’ minuscule chances for success and instead use them to gin up controversy and interest in their cause, which is always a great way to get a few email addresses or financial contributions–some petitions even have a convenient donate button right next to where you “sign” your name!

A quick google search for “gm labeling petition” pulls up, well, more petitions than I really care to count. Most make seemingly modest demands about the “right to know,” consumer education, and truth in advertising. Is that an accurate view of the debate: Consumer education versus corporate secrecy? Truth is, the legal reality is a little more complex than these petitions would seem to indicate. Below, I’ve written a short synopsis of the government’s current stance on GMO labeling. It’s written for people without any legal training, so it’s only a sketch. I’ve also listed a few helpful resources at the bottom for anyone who wants to dig a little deeper. This is exclusively about U.S. law, but in future posts, I’ll discuss recent developments in the biotech laws of Canada, the European Union, and Japan.

Food Labeling in the U.S.

In the U.S., food labeling is overseen by the FDA according to the Food, Drug, and Cosmetic Act (FDCA). The FDA first discussed the labeling of biotechnology food products in 1992, with a policy statement titled “Foods Derived From New Plant Varieties.” In it, the FDA said it had no reason to single out bioengineered foods for special labeling, because recombinant DNA techniques were really just extensions of traditional methods for developing new plant varieties–such as hybridization–which had not received special attention in the past. Without decent evidence that bioengineered foods differed from their conventional counterparts in terms of safety, the FDA determined that they should be labeled with the same name (called the “common” or “usual” name) as the conventional crop (i.e., “corn” or “tomatoes”).

Safety is basically the main issue whenever the FDA requires new labeling for foods. For instance, if a tomato is created using a peanut protein, the FDA may require its producer to put a label saying “this tomato has been bioengineered with a peanut protein that may be allergenic to some individuals with nut allergies.” In the past, the courts have found that consumer curiosity alone is not enough to require special labeling (see International Dairy Foods Assoc. v. Amestoy, 92 F.3d 67 (2d Cir. 1996). http://openjurist.org/92/f3d/67; Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000)). The reasoning behind this is simple: First, it places an enormous financial burden on industries that would have to investigate, document, and label the “level” of bioengineering that went into their product; second, it may mislead consumers into thinking that bioengineered crops are somehow less safe than their conventional counterparts; third, it places a burden on the FDA itself which must then divert efforts from safety labeling issues to consumer curiosity labeling issues; and fourth, it places no end on the information that consumers could require manufacturers to disclose.

Some groups are now demanding that the FDA allow voluntary labeling for “No GMO” or “GMO Free” products. While the FDA does not punish producers for labeling their products as such, they do discourage that practice. In January 2001, the FDA announced a “draft guidance” (a non-binding document that informally tells people how to act in a way that won’t attract the ire of the agency) outlining the reasons against voluntary labeling of food products as “GMO Free.” The FDA had three major concerns, which I’ve taken the liberty of paraphrasing below:

1) that the terms “GMO,” “GM,” and “GE,” were not technically precise and did nothing to inform the average consumer, and that “genetic modification” was overly broad, since it would include conventional means of generating new plant varieties (the FDA prefers the terms “bioengineering” or “biotechnology”–which they use interchangeably–to distinguish newer transgenic processes from conventional practices);

2) that the term “free” implied “zero,” and that the prevalence of bioengineered products made such a claim false, misleading, or unprovable; and

3) that the label would be misleading to the extent that it implied that foods not labeled as “GMO free” were in some way unsafe or inferior (a claim that is, in the FDA’s opinion, unsubstantiated by the scientific literature).

The FDA did express support for certain types of voluntary labeling, so long as the information contained therein is not vague or inaccurate. For example, a producer may use a label that says “Our tomato growers do not plant seeds developed using biotechnology” (assuming such a label would be accurate). On the other side, another producer may use a label that says “Our tomato growers use genetically engineered tomato seeds to increase total crop yields,” adding a purposive explanation to the label for greater consumer understanding. The FDA reserves the right to ask for substantiation, through validated testing means or appropriate record keeping, for any claims a producer makes through labeling. A quick side note: this draft guidance has been neither finalized nor withdrawn since its announcement almost nine years ago, and therefore does not itself create legal duties or liabilities. In the meantime, the FDA has not chosen to actually go after anyone touting their product as “GMO Free,” despite their draft guidance. Just today I drank an overpriced (but tasty) Odwalla juice that proudly advertised itself as “No GMO.”

So, if you want to label your product “GMO Free,” knock yourself out–the FDA probably won’t do anything (except maybe send you a strongly worded letter if you’re being blatantly dishonest). As for mandatory labeling, I hate to break it to the numerous purveyors of all those internet petitions, but the FDA is unlikely–absent some very convincing evidence showing the danger of bioengineered food (and, no, eyewitness reports of chickens turning their noses up at Bt corn do not count)–to reconsider its position on the matter. This might change through two ways: Either the FDA can initiate a rule-making procedure to make consumer curiosity a material issue (highly unlikely and easily challenged in court), or Congress can amend the FDCA to make special provisions for bioengineered products (still a longshot considering it doesn’t have traction right now, but you never know). Technically, President Obama, et al. have little, if anything, to do with the decision, so petitions directed towards them will have no effect on the labeling law. But they sure are a good way to add emails to your list-serv!

Disclaimer: The information contained on this page has been compiled for educational purposes only; though it is wholly accurate to the best knowledge of me, the author, it does not constitute legal advice and should not be taken as such.

References:

FDA policy statement for regulating biotechnology products. 43 Fed. Reg. 50878 (Dec. 31, 1984), 51 Fed. Reg. 23309 (June 26, 1986).

Food and Drug Administration, Statement of Policy: Foods Derived From New Plant Varieties. 57 Fed. Reg. 22984 (May 29, 1992).

International Dairy Foods Assoc. v. Amestoy, 92 F.3d 67 (2d Cir. 1996). http://openjurist.org/92/f3d/67

Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000).

Food and Drug Administration, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance. 66 Fed. Reg. 4839 (Jan. 18, 2001). http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059098.htm

Rob Hebert is a second-year student at Georgetown Law. Before moving to DC, he lived in Brooklyn, NY, just blocks from a bar that had over twenty-five beers on tap and thirty arcade machines that all played for a quarter. He can draw you a pretty interesting graph relating “Drinks Consumed” to “Last Score on Pac-Man.”

By Melinda Yerka

This is a painting done by Sir Charles Bell in 1809 of a soldier dying of tetanus.  Doesn’t look too comfortable, hmm?  Tetanus is a condition brought on when certain bacteria, called Clostridium tetani, enter deep puncture wounds, such as the proverbial rusty nail, or in this soldier’s case, a dirty sword in battle.  Once inside the wound, C. tetani bacteria produce the tetanus toxin, which then migrates to the body’s central nervous system where it causes tetanus disease, characterized by intense muscle spasms.  70% to 80% of the people who contract tetanus die.  Unfortunately, many of these people today are newborn infants and their mothers.  Infection by C. tetani bacteria occurs in these cases when unclean instruments are used to cut umbilical cords or remove a fetus from the mother’s womb during live birth or abortion.  If the mother had been immunized against tetanus toxin, she and the infant (who would be born with some of its mother’s immunities) would have survived.

You may wonder why the mother was not immunized when vaccines against tetanus have been readily available for more than a generation.  In fact, it is because vaccinations are far less prevalent in poor countries than in wealthier nations such as the United States and much of Europe.  Furthermore, despite growing humanitarian interest in providing vaccines, the infrastructure of many developing nations is not sufficient to safely synthesize, transport, or store them.  Lack of pharmaceutical companies, efficient transportation systems, refrigerated warehouses, and knowledgeable physicians all play a role in the continued fight against tetanus.  Nevertheless, progress has been made since the early 1980′s, as depicted below in a graph from the World Health Organization (WHO).

On the left y-axis is the number of tetanus cases per year from all around the world.  The blue bars represent the number of cases for each year listed on the x-axis, from 1980 to 2007.  On the right y-axis is the percent of the population that has been immunized against tetanus via the DTP3 vaccine for each year.  The blue line represents the percent of people who “officially” received the vaccine, and the red dotted line represents the percent of people who WHO and UNICEF estimate actually received it.  Note the sharp decline in the number of tetanus cases between 1980 and 1995.  This is largely due to a tremendous humanitarian undertaking by UNICEF to stamp out the disease.  However, even as recently as 2007, nearly 20,000 cases per year still occur.  Clearly more work remains to be done.

A novel approach to vaccination has been suggested since the mid-1990′s when genetically engineered plants began to gain rapid adoption on farms.  Genetic engineering’s first really big commercial success came in the form of incorporating herbicide resistance by way of a human-created transgene into crop plants.  As a result, a farmer could sow (for example) soybeans resistant to a particular herbicide, and then when weeds became a problem throughout the year, (s)he could simply spray that herbicide.  All of the plants in the field except her/his soybeans would die; hence, the birth of much simplified weed control.  But then came a leap of insight:  why not breed vaccines into plants, too?  Seeds do not require refrigeration to transport and store, nor a pharmaceutical company to produce them.

Researchers in Europe studied the possibility of incorporating a gene from C. tetani bacteria themselves, bearing resistance to the tetanus toxin, into plants.  A series of feasibility studies have been conducted and their results were published by Tregoning et al. in 2005 in the European Journal of Immunology, volume 35, pp. 1320-1325.  The title of their paper was “Protection against tetanus toxin using a plant-based vaccine.“  In it, they report transforming the chloroplasts of tobacco plants with a gene that codes for a fragment of a protein from C. tetani that can elicit an immune response. In other words, biotechnology was used to produce a vaccine against tetanus inside tobacco plants.  Tregoning et al. then immunized mice via a nasal spray (previously shown to be the most effective means of delivery) with a protein extract from transformed tobacco plants, and subsequently subjected them to a lethal dose of tetanus toxin.  All mice that received the plant-based vaccine survived, while all mice that did not receive the vaccine died.

Their results are shown in the graph below.

On the y-axis is the amount of tetanus antibodies (abbreviated Anti-TetC Ig) in the mice’s blood samples.  On the x-axis are the different groups of mice in the study.  The Tet x1 group received the tetanus vaccine once; the Tet x2 group received it twice, the Tet x2 + CT group received it twice in addition to a cholera adjuvant designed to elicit a stronger immunity response to tetanus; finally the control group did not receive a vaccine.  Where a star is above a particular group of mice’s result, it means that the average performance of that group was significantly different than the average performance of the control group.  Four mice were tested in each group, and as you can see, every mouse that received the nasal spray made from the transgenic tobacco plants survived, while every mouse that didn’t died.

While it is unlikely that such transgenic tobacco plants will be grown in Africa or Southeast Asia anytime soon (no tests have yet been conducted on humans), the implications of this work are nevertheless far-reaching.  They constitute the first clear proof that plants can be used to confer resistance to tetanus in mammals, and continue to push open the door that will hopefully, one day, lead to equal access to basic health care around the world.

Melinda Yerka is a graduate student studying Plant Breeding and Plant Genetics at UW-Madison. When she’s not growing weeds in the greenhouse for her research, she’s plucking weeds in her organic community garden plots.