Vaccine misinformation

From Wikipedia, the free encyclopedia

https://en.wikipedia.org/wiki/Vaccine_misinformation 

See also: COVID-19 vaccine misinformation and hesitancy

Misinformation related to immunization and the use of vaccines circulates in mass media and social media in spite of the fact that there is no serious hesitancy or debate within mainstream medical and scientific circles about the benefits of vaccination. Unsubstantiated safety concerns related to vaccines are often presented on the internet as being scientific information. A high proportion of internet sources are "inaccurate on the whole" which can lead people searching for information to form "significant misconceptions about vaccines".

Although opposition to vaccination has existed for centuries, the internet and social media have recently facilitated the spread of vaccine-related misinformation. Intentional spreading of false information and conspiracy theories have been propagated by the general public and celebrities. Active disinformation campaigns by foreign actors are related to increases in negative discussions online and decreases in vaccination use over time. 

Misinformation related to vaccination leads to vaccine hesitancy which fuels disease outbreaks. As of 2019, prior to the COVID-19 pandemic, vaccine hesitancy was considered one of the top ten threats to global health by the World Health Organization.

Extent

A survey by the Royal Society for Public Health found that 50% of the parents of children under the age of five regularly encountered misinformation related to vaccination on social media. On Twitter, bots, masked as legitimate users were found creating false pretenses that there are nearly equal number of individuals on both sides of the debate, thus spreading misleading information related to vaccination and vaccine safety. The accounts created by bots use additional compelling stories related to anti-vaccination as clickbait to drive up their revenue and expose users to malware.

A study revealed that Michael Manoel Chaves, an ex-paramedic who was sacked by the NHS for Gross Misconduct after stealing from two patients he was treating, is involved with the anti-vaccine community. These are the type of individuals who were previously interested in alternative medicine or conspiracy theories. Another study showed that a predisposition to believe in conspiracy theories was negatively correlated to the intention of individuals to get vaccinated.

Spreading vaccine misinformation can lead to financial rewards by posting on social media and asking for donations or fundraising for anti-vaccination causes.

List of popular misinformation

The World Health Organization has classified vaccine related misinformation into five topic areas. These are: threat of disease (vaccine preventable diseases are harmless), trust (questioning the trustworthiness of healthcare authorities who administer vaccines), alternative methods (such as alternative medicine to replace vaccination), effectiveness (vaccines do not work) and safety (vaccines have more risks than benefits).

Vaccination causes idiopathic illnesses

• Vaccines cause autism: The established scientific consensus is that there is no link between vaccines and autism. No ingredients in vaccines, including thiomersal, have been found to cause autism. The incorrect claim that vaccines cause autism dates to a paper published in 1998 and since retracted. In the late 1990s' a physician at Royal Free Hospital by the name of Andrew Wakefield published an article claiming to have found an explanation for autism. He first reported a relationship between measles virus and colonic lesions in Crohn's disease, which was soon disproved. He next hypothesized that the MMR triad vaccine, the vaccine for measles, triggered colonic lesions that disrupted the colon's permeability, causing neurotoxic proteins to enter the bloodstream, eventually reach the brain and result in autistic symptoms. The article was partially retracted by The Lancet as of March 6, 2004 after journalist Brian Deer raised issues including the possibility of severe research misconduct, conflict of interest and probable falsehood. The paper was fully retracted as of February 2, 2010, following an investigation of the flawed study by Britain’s General Medical Council which supported those concerns. The British Medical Association took disciplinary action against Wakefield on May 24, 2010, revoking his right to practice medicine. There are some indications that people with autism may also tend to have gastrointestinal disorders. However, multiple large scale studies of more than half a million children have been carried out without finding a causal link between MMR vaccines and autism.
• Vaccines can cause the same disease that one is vaccinated against: A vaccine causing complete disease is extremely unlikely. In traditional vaccines, the virus is attenuated (weakened) and thus it is not possible to contract the disease, while in newer technologies like mRNA vaccines the vaccine does not contain the virus at all.
• Vaccines cause harmful side effects and even death: Vaccines are very safe. Most adverse events after vaccination are mild and temporary, such as a sore throat or mild fever, which can be controlled by taking paracetamol after vaccination.
• Vaccines will cause infertility: There is no supporting evidence or data that any vaccines have a negative impact on women's fertility. In 2020, as COVID-19 numbers rose and vaccinations started to roll out, the misinformation around vaccines causing infertility began to circulate. The false narrative began that mRNA vaccine-induced antibodies which act against the SARS-CoV-2 spruce protein could also attack the placental protein syncytin-1, and that this could cause infertility. There is no evidence to support this. A joint statement of the The American College of Obstetricians and Gynecologists, the the American Society for Reproductive Medicine, and the the Society for Maternal-Fetal Medicine clearly states “that there is no evidence that the vaccine can lead to loss of fertility”.

Alternative remedies to vaccination

Responding to misinformation, some may resort to complementary or alternative medicine as an alternative to vaccination. Those who believe in this narrative view vaccines as 'toxic and adulterating' while seeing alternative 'natural' methods as safe and effective. Some of the misinformation circulating around alternate remedies for vaccination include:

• Eating yoghurt cures human papillomavirus: Eating any natural product does not prevent or cure HPV.
• Homeopathy can be used as an alternative to protect against measles: Homeopathy has been shown to be ineffective against preventing measles.
• Quercetin, zinc, vitamin D, and other nutritional supplements can protect from/tread COVID-19: none of the above can prevent or treat COVID-19.
• Nosodes are an alternative to vaccines: There is no evidence supporting nosodes effectiveness in preventing or treating infectious diseases.

Vaccination as genocide

Misinformation that forced vaccination could be used to "depopulate" the earth circulated in 2011 by misquoting Bill Gates. There is misinformation implying that vaccines (particularly the mRNA vaccine) could alter DNA in the nucleus. mRNA in the cytosol is very rapidly degraded before it would have time to gain entry into the cell nucleus. (mRNA vaccines must be stored at very low temperature to prevent mRNA degradation.) Retrovirus can be single-stranded RNA (just as SARS-CoV-2 vaccine is single-stranded RNA) which enters the cell nucleus and uses reverse transcriptase to make DNA from the RNA in the cell nucleus. A retrovirus has mechanisms to be imported into the nucleus, but other mRNA lack these mechanisms. Once inside the nucleus, creation of DNA from RNA cannot occur without a primer, which accompanies a retrovirus, but which would not exist for other mRNA if placed in the nucleus.^[36][37] Thus, mRNA vaccines cannot alter DNA because they cannot enter the nucleus, and because they have no primer to activate reverse transcriptase.

Vaccine components contain forbidden additives

Anti-vaxxers emphasize that the components in vaccines such as thiomersal and aluminum are capable for causing health hazards. Thiomersal is a harmless component in vaccines which is used to maintain its sterility, and there are no known adverse effects due to it. Aluminium is included in the vaccine as an adjuvant, and it has low toxicity even in large amounts. Formaldehyde included in some vaccines is in negligibly low quantities and it is harmless. Narratives that COVID-19 vaccines contain haram products were circulated in Muslim communities.

Vaccines are part of a governmental/pharmaceutical conspiracy

The Big Pharma conspiracy theory, that pharmaceutical companies operate for sinister purposes and against the public good, has been used in the context of vaccination.

Vaccine preventable diseases are harmless

There is a common misconception that vaccine-preventable diseases such as measles are harmless. However, measles remains a serious disease, and can cause severe complications or even death. Vaccination is the only way to protect against measles.

Personal anecdotes about harmed individuals

Personal anecdotes and sometimes false stories are circulated about vaccination. Misinformation has spread claiming that people died due to COVID-19 vaccination. There are individuals that perpetuate the harmful mistruths about vaccinations and the falsified links vaccinations have with autism. Through the spread of false media, civilians are blindly being led to believe that vaccinations are the leading cause of autism, when in fact, this is far from the truth. For one, autism occurs during fetal development, not after the mother has given birth (Rodier, P. M. 2000). However, there are contributing factors that can influence where a child may be placed on the spectrum. These factors include the mother consuming medication while pregnant that should not be consumed during pregnancy, genetics playing a part, the environment as well as metabolic disorders and epigenetic mechanisms (Manzi, B. et al. 2008). Though individuals tend to believe that autism is a harmful and negative disorder—and therefore refusing to be vaccinated—they are actually causing more harm to themselves and others by potentially putting themselves at risk of being exposed to diseases and infections that can be harmful to their body. More so over, when infected, they can then transfer the disease to a person who is immunocompromised. This not only harms themselves but can contribute to the spread of viral infections with harmful long-term effects that can potentially result in death. All in all, through the many experiments performed on the links between vaccinations and autism, no experiment has conclusively proven the link between autism and vaccinations.

Vaccine-preventable diseases have been eradicated

Vaccination has enabled the reduction of most vaccine-preventable diseases (e.g. Polio has been eradicated in every country except Afghanistan and Pakistan). However, some are still prevalent and even cause epidemics in some parts of the world. If the affected population is not protected by vaccination, the disease can quickly spread from country to country. Vaccines do not only protect the individual, but also lead to herd immunity if a sufficient number of people in the population have taken the vaccine.

Other conspiracy theories

Other conspiracy theories circulated on social media have included the false notion such as;

• Polio is not a real disease and the symptoms are actually due to DDT poisoning: The first major documented polio outbreak in the United States occurred in 1894 in Vermont. In the early 20th century, a polio epidemic started in the west causing 6,000 deaths and leaving 27,000 people paralyzed. In 1954, the Salk Institute created the polio vaccine putting an end to the epidemic and saving millions of lives. The incorrect theory that polio was related to pesticide poisoning predates the discovery of the polio vaccine. It was proposed in 1952 by Dr. Ralph R. Scobey in an article in the Archives of Pediatrics. Scobey argued that there were similarities between the symptoms of polio and various types of poisoning, and suggested that polio outbreaks might be more likely to occur during the summer and be related to consumption of fresh fruit and vegetables. While pesticides such as DDT are dangerous, as was shown by Rachel Carson in Silent Spring in 1962, they are not dangerous in the way that Scobey believed them to be, as a cause of polio. Studies have clearly demonstrated causal relationships showing that polio is caused by a virus. Vaccines have proven effective in preventing the disease and eliminating wild poliovirus in most parts of the world.
• NASA is releasing balloons filled with chemicals that produce polio-like symptoms.
• The COVID-19 vaccines contain injectable microchips to identify and track people: This conspiracy theory started circulating in 2020 claiming the COVID-19 pandemic was a cover for a plan to implant trackable microchips and Bill Gates, co-founder of Microsoft, was behind it. Recent polls suggest that 28% of Americans believe in this conspiracy theory.

Impact

Fueled by misinformation, anti-vaccination activism is on the rise on social media and in many countries. Research has shown that viewing a website containing vaccine misinformation for 5–10 minutes decreases a person's intention to vaccinate. A 2020 study found that "large proportions of the content about vaccines on popular social media sites are anti-vaccination messages." It further found that there is a significant relationship between joining vaccine hesitant groups on social media and openly casting doubts in public about vaccine safety, as well as a substantial relationship between foreign disinformation campaigns and declining vaccination coverage.

In 2003, rumors about polio vaccines intensified vaccine hesitancy in Nigeria and led to a five-fold increase in the number of polio cases in the country over three years. A 2021 study found that misinformation about COVID-19 vaccines on social media "induced a decline in intent [to vaccinate] of 6.2 percentage points in the [United Kingdom] and 6.4 percentage points in the [United States] among those who said they would definitely accept a vaccine".

Measures against misinformation

Several governmental agencies, such as the Centers for Disease Control (CDC) in the United States and National Health Service (NHS) in the United Kingdom have dedicated webpages for addressing vaccine-related misinformation. Pinterest was one of the first social media platforms to surface only trustworthy information from reliable sources on their vaccine related searches back in 2019. In 2020, Facebook announced that it would no longer allow anti-vaccination advertisements on its platform. Facebook also said it would elevate posts from the World Health Organization and UNICEF in order to increase immunization rates through public health campaigns. Twitter announced that it would put a warning label on tweets containing disputed or unsubstantiated rumors about vaccination and require users to remove tweets that spread false information about vaccines. TikTok announced that it would start directing people to official health sources when they search for vaccine related information. By December 2020, YouTube had removed more than 700,000 videos containing misinformation related to COVID-19.

Research shows that science communicators should directly counter misinformation because of its negative influence on silent audience who are observing the vaccine debate, but not engaging in it. The refutations to vaccine-related misinformation should be straightforward in order to avoid emphasizing misinformation. It is useful to pair scientific evidence with stories that connect to the belief and value system of the audience.

While social media companies have taken recent steps to reduce the presence of vaccine misinformation on their platforms, misinformed users and their social groups remain. After repeated exposure, these individuals now hold misinformed mental models of the function, risk, and purpose of vaccines. The longer an individual holds misinformation, the more staunchly rooted it becomes in their mental model, making its correction and retraction all the more difficult. Over time, these models may become integral to a vaccine hesitant individual's worldview. People are likely to filter any new information they receive to fit their preexisting worldview – corrective vaccine facts are no exception to this motivated reasoning. Thus, by the time vaccine hesitant individuals arrive at the doctor's office, healthcare workers face an uphill battle. If they seek to change minds and maintain herd immunity against preventable diseases, they must do more than simply present facts about vaccines. Providers need communication strategies that effectively change minds and behavior.

Given the complexity of this problem, effective evidence-based strategies have yet to be identified. Interventions for parents/caregivers who make health decisions for their children are vital. In the United States, the CDC recommends at least 15 vaccinations during the first 18 years of life, given parental consent. This set includes the measles, mumps, and rubella (MMR) vaccine – the central immunization of concern for misinformed parents. Debunked research and celebrity anecdotes that falsely linked the MMR vaccine to autism still have a strong hold on parental behaviors. In 15 states, MMR vaccination rates are below 90%. The necessity to counteract misinformation among parents is clear, but the pathway forward is not – researchers are still looking for answers.

Although many wish to provide families with as much corrective information as possible, this often has unintended consequences. One study in 2013 tested four separate interventions to correct MMR vaccine misinformation and promote parental behavioral change: (1) Provide information explaining lack of evidence that MMR causes autism. (2) Present textual information about the dangers of measles, mumps, and rubella. (3) Show images of children with measles, mumps and rubella. (4) Provide a dramatic written narrative about an infant who became deathly ill from measles. Before and after each intervention, researchers measured parents' belief in the vaccine/autism misperception, their intent to vaccinate future children, and their general risk perception of the vaccine. They found that none of the interventions increased parental intent to vaccinate.

Instead, the first intervention (1) reduced misperceptions about autism, but still decreased parents' intent to vaccinate future children. Notably, this effect was significant among parents who were already the most vaccine-hesitant. Nyhan et al. conclude that corrective information may backfire. Motivated reasoning could be the mechanism behind this finding – no matter how many facts are provided, parents still sift through them to selectively find those that support their worldview. While the corrective information did have an effect on a specific belief, ultimately vaccine-hesitant parents used this additional information to strengthen their original behavioral intent. Interventions three and four increased the vaccine/autism misperception and increased belief in serious vaccine side effects, respectively. The authors attribute this result to a potential danger priming effect – when pushed into a fearful state, parents misattribute this fear to the vaccine itself, rather than the diseases it prevents. In all cases, the facts included had little, if not counterproductive effect on future behaviors.

This work has important implications for future research. First, the study's findings revealed a disparity between beliefs and intentions – even as specific misperceptions are corrected, behavior may not change. Since reaching herd immunity for preventable diseases requires promoting a behavior – vaccination – it is important for future research to measure behavioral intent, rather than just beliefs. Second, it is imperative for all health messaging to be tested before its widespread use. Society does not necessarily know the behavioral impacts of communication interventions – they may have unintended consequences on different groups. In the case of correcting vaccine misinformation and changing vaccination behaviors, much more research is still needed to identify effective communication strategies.

Health impact assessment

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https://en.wikipedia.org/wiki/Health_impact_assessment

Health impact assessment (HIA) is defined as "a combination of procedures, methods, and tools by which a policy, program, or project may be judged as to its potential effects on the health of a population, and the distribution of those effects within the population." (ECHP 1999, p. 4)

Overview

HIA is intended to produce a set of evidence-based recommendations to inform decision-making (Taylor & Quigley 2002, p. 2). HIA seeks to maximise the positive health impacts and minimise the negative health impacts of proposed policies, programs or projects.

The procedures of HIA are similar to those used in other forms of impact assessment, such as environmental impact assessment or social impact assessment. HIA is usually described as following the steps listed, though many practitioners break these into sub-steps or label them differently:

1. Screening - determining if an HIA is warranted/required
2. Scoping - determining which impacts will be considered and the plan for the HIA
3. Identification and assessment of impacts - determining the magnitude, nature, extent and likelihood of potential health impacts, using a variety of different methods and types of information
4. Decision-making and recommendations - making explicit the trade-offs to be made in decision-making and formulating evidence-informed recommendations
5. Evaluation, monitoring and follow-up - process and impact evaluation of the HIA and the monitoring and management of health impacts

The main objective of HIA is to apply existing knowledge and evidence about health impacts, to specific social and community contexts, to develop evidence-based recommendations that inform decision-making in order to protect and improve community health and wellbeing. Because of financial and time constraints, HIAs do not generally involve new research or the generation of original scientific knowledge. However, the findings of HIAs, especially where these have been monitored and evaluated over time, can be used to inform other HIAs in contexts that are similar. An HIA's recommendations may focus on both design and operational aspects of a proposal.

HIA has also been identified as a mechanism by which potential health inequalities can be identified and redressed prior to the implementation of proposed policy, program or project (Acheson 1998).

A number of manuals and guidelines for HIA's use have been developed (see further reading).

Determinants of health

The proposition that policies, programs and projects have the potential to change the determinants of health underpins HIA's use. Changes to health determinants then leads to changes in health outcomes or the health status of individuals and communities. The determinants of health are largely environmental and social, so that there are many overlaps with environmental impact assessment and social impact assessment.

Levels of HIA

Three forms of HIA exist:

• Desk-based HIA, which takes 2–6 weeks for one assessor to complete and provides a broad overview of potential health impacts;
• Rapid HIA, which takes approximately 12 weeks for one assessor to complete and provides more detailed information on potential health impacts; and
• Comprehensive HIA, which takes approximately 6 months for one assessor and provides a in-depth assessment of potential health impacts. (IMPACT 2004, p. 7)

It has been suggested that HIAs can be prospective (done before a proposal is implemented), concurrent (done while the proposal is being implemented) or retrospective (done after a proposal has been implemented) (Taylor, Gorman & Quigley 2003, p. 1). This remains controversial, however, with a number of HIA practitioners suggesting that concurrent HIA is better regarded as a monitoring activity and that retrospective HIA is more akin to evaluation with a health focus, rather than being assessment per se (Kemm 2003, p. 387). Prospective HIA is preferred as it allows the maximum practical opportunity to influence decision-making and subsequent health impacts.

HIA practitioners

HIA practitioners can be found in the private and public sectors, but are relatively few in number. There are no universally accepted competency frameworks or certification processes. It is suggested that a lead practitioner should have extensive education and training in a health related field, experience of participating in HIAs, and have attended an HIA training course. It has been suggested and widely accepted that merely having a medical or health degree should not be regarded as an indication of competency.

The International Association for Impact Assessment has an active health section.

A HIA People Directory can be found on the HIA GATEWAY.

HIA worldwide

HIA used around the world, most notably in Europe, North America, Australia, New Zealand, Africa and Thailand (Winkler et al. 2020).

The safeguard policies and standards of the International Finance Corporation (IFC), part of the World Bank, were established in 2006. These contain a requirement for health impact assessment in large projects. The standards have been accepted by most of the leading lending banks who are parties to the Equator Principles. Health impact assessments are becoming routine in many large development projects in both public and private sectors of developing countries. There is also a long history of health impact assessment in the water resource development sector - large dams and irrigation systems.

Precautionary principle

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For the Wikipedia guideline, see Wikipedia:Precautionary principle.

The precautionary principle (or precautionary approach) is a broad epistemological, philosophical and legal approach to innovations with potential for causing harm when extensive scientific knowledge on the matter is lacking. It emphasizes caution, pausing and review before leaping into new innovations that may prove disastrous. Critics argue that it is vague, self-cancelling, unscientific and an obstacle to progress.

In an engineering context, the precautionary principle manifests itself as the factor of safety, discussed in detail in the monograph of Elishakoff. It was apparently suggested, in civil engineering, by Belindor in 1729. Interrelation between safety factor and reliability is extensively studied by engineers and philosophers.

The principle is often used by policy makers in situations where there is the possibility of harm from making a certain decision (e.g. taking a particular course of action) and conclusive evidence is not yet available. For example, a government may decide to limit or restrict the widespread release of a medicine or new technology until it has been thoroughly tested. The principle acknowledges that while the progress of science and technology has often brought great benefit to humanity, it has also contributed to the creation of new threats and risks. It implies that there is a social responsibility to protect the public from exposure to such harm, when scientific investigation has found a plausible risk. These protections should be relaxed only if further scientific findings emerge that provide sound evidence that no harm will result.

The principle has become an underlying rationale for a large and increasing number of international treaties and declarations in the fields of sustainable development, environmental protection, health, trade, and food safety, although at times it has attracted debate over how to accurately define it and apply it to complex scenarios with multiple risks. In some legal systems, as in law of the European Union, the application of the precautionary principle has been made a statutory requirement in some areas of law.

Origins and theory

The concept "precautionary principle" is generally considered to have arisen in English from a translation of the German term Vorsorgeprinzip in the 1970s in response to forest degradation and sea pollution, where German lawmakers adopted clean air act banning use of certain substances suspected in causing the environmental damage even though evidence of their impact was inconclusive at that time. The concept was introduced into environmental legislation along with other innovative (at that time) mechanisms such as "polluter pays", principle of pollution prevention and responsibility for survival of future ecosystems.

The precautionary principle was promulgated in philosophy by Hans Jonas in his 1979 text, The Imperative of Responsibility, wherein Jonas argued that technology had altered the range of the impact of human action and, as such, ethics must be modified so that the far distant effects of one's actions should now be considered. His maxim is designed to embody the precautionary principle in its prescription that one should "Act so that the effects of your action are compatible with the permanence of genuine human life" or, stated conversely, "Do not compromise the conditions for an indefinite continuation of humanity on earth." To achieve this Jonas argued for the cultivation of a cautious, even fearful attitude, toward actions that may endanger the future of humanity or the biosphere that supported it.

In 1988, Konrad von Moltke described the German concept for a British audience, which he translated into English as the precautionary principle.

In economics, the Precautionary Principle has been analyzed in terms of "the effect on rational decision-making", of "the interaction of irreversibility" and "uncertainty". Authors such as Epstein (1980) and Arrow and Fischer (1974) show that "irreversibility of possible future consequences" creates a "quasi-option effect" which should induce a "risk-neutral" society to favour current decisions that allow for more flexibility in the future. Gollier et al. conclude that "more scientific uncertainty as to the distribution of a future risk – that is, a larger variability of beliefs – should induce society to take stronger prevention measures today."

The principle was also derived from religious beliefs that particular areas of science and technology should be restricted as they "belong to the realm of God", as postulated by Prince Charles and Pope Benedict XVI.

Formulations

Many definitions of the precautionary principle exist: Precaution may be defined as "caution in advance", "caution practiced in the context of uncertainty", or informed prudence. Two ideas lie at the core of the principle:

• an expression of a need by decision-makers to anticipate harm before it occurs. Within this element lies an implicit reversal of the onus of proof: under the precautionary principle it is the responsibility of an activity-proponent to establish that the proposed activity will not (or is very unlikely to) result in significant harm.
• the concept of proportionality of the risk and the cost and feasibility of a proposed action.

One of the primary foundations of the precautionary principle, and globally accepted definitions, results from the work of the Rio Conference, or "Earth Summit" in 1992. Principle 15 of the Rio Declaration notes:

In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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

In 1998 Wingspread Statement on the Precautionary Principle was convened by the Science and Environmental Health Network and concluded with the following formulation, described by Stewart Brand as "the clearest and most frequently cited":

When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof.

In February 2000, the Commission of the European Communities noted in a Communication from the Commission on the Precautionary Principle that, "The precautionary principle is not defined in the Treaties of the European Union, which prescribes it [the Precautionary Principle] only once – to protect the environment. But in practice, its scope is much wider, and specifically where preliminary-objective-scientific-evaluation indicates that there are reasonable grounds for concern that potentially dangerous effects on the environment, human, animal or [and] plant health may be inconsistent with the high level of protection [for what] chosen for the Community."

The January 2000 Cartagena Protocol on Biosafety says, in regard to controversies over GMOs: "Lack of scientific certainty due to insufficient relevant scientific information ... shall not prevent the Party of [I]mport, in order to avoid or minimize such potential adverse effects, from taking a decision, as appropriate, with regard to the import of the living modified organism in question."

Application

Various interests being represented by various groups proposing the principle resulted in great variability of its formulation: one study identified 14 different formulations of the principle in treaties and non-treaty declarations. R.B. Stewart (2002) reduced the precautionary principle to four basic versions:

• Scientific uncertainty should not automatically preclude regulation of activities that pose a potential risk of significant harm (non-preclusion).
• Regulatory controls should incorporate a margin of safety; activities should be limited below the level at which no adverse effect has been observed or predicted (margin of safety).
• Activities that present an uncertain potential for significant harm should be subject to best technology available requirements to minimize the risk of harm unless the proponent of the activity shows that they present no appreciable risk of harm (BAT).
• Activities that present an uncertain potential for significant harm should be prohibited unless the proponent of the activity shows that it presents no appreciable risk of harm (prohibitory).

Carolyn Raffensperger of the Wingspread convention placed the principle in opposition to approaches based on risk management and cost-benefit analysis. Dave Brower (Friends of the Earth) concluded that "all technology should be assumed guilty until proven innocent". Freeman Dyson described the application of precautionary principle as "deliberately one-sided", for example when used as justification to destroy genetic engineering research plantations and threaten researchers in spite of scientific evidence demonstrating lack of harm.

The Precautionary Principle says that if some course of action carries even a remote chance of irreparable damage to the ecology, then you shouldn't do it, no matter how great the possible advantages of the action may be. You are not allowed to balance costs against benefits when deciding what to do.

— Freeman Dyson, Report from 2001 World Economic Forum

As noted by Rupert and O'Riordan, the challenge in application of the principle is "in making it clear that absence of certainty, or there being insufficient evidence-based analysis, were not impediments to innovation, so long as there was no reasonable likelihood of serious harm". Lack of this nuanced application makes the principle "self-cancelling" according to Stewart Brand, because "nothing is fully established" in science, starting from the precautionary principle itself and including "gravity or Darwinian evolution". A balanced application should ensure that "precautionary measures should be" only taken "during early stages" and as "relevant scientific evidence becomes established", regulatory measures should only respond to that evidence.

Strong vs. weak

Strong precaution holds that regulation is required whenever there is a possible risk to health, safety, or the environment, even if the supporting evidence is speculative and even if the economic costs of regulation are high. In 1982, the United Nations World Charter for Nature gave the first international recognition to the strong version of the principle, suggesting that when "potential adverse effects are not fully understood, the activities should not proceed". The widely publicised Wingspread Declaration, from a meeting of environmentalists in 1998, is another example of the strong version. Strong precaution can also be termed as a "no-regrets" principle, where costs are not considered in preventative action.

Weak precaution holds that lack of scientific evidence does not preclude action if damage would otherwise be serious and irreversible. Humans practice weak precaution every day, and often incur costs, to avoid hazards that are far from certain: we do not walk in moderately dangerous areas at night, we exercise, we buy smoke detectors, we buckle our seatbelts.

According to a publication by the New Zealand Treasury Department,

The weak version [of the Precautionary Principle] is the least restrictive and allows preventive measures to be taken in the face of uncertainty, but does not require them (e.g., Rio Declaration 1992; United Nations Framework Convention of Climate Change 1992). To satisfy the threshold of harm, there must be some evidence relating to both the likelihood of occurrence and the severity of consequences. Some, but not all, require consideration of the costs of precautionary measures. Weak formulations do not preclude weighing benefits against the costs. Factors other than scientific uncertainty, including economic considerations, may provide legitimate grounds for postponing action. Under weak formulations, the requirement to justify the need for action (the burden of proof) generally falls on those advocating precautionary action. No mention is made of assignment of liability for environmental harm. Strong versions justify or require precautionary measures and some also establish liability for environmental harm, which is effectively a strong form of "polluter pays". For example, the Earth Charter states: "When knowledge is limited apply a precautionary approach ... Place the burden of proof on those who argue that a proposed activity will not cause significant harm, and make the responsible parties liable for environmental harm." Reversal of proof requires those proposing an activity to prove that the product, process or technology is sufficiently "safe" before approval is granted. Requiring proof of "no environmental harm" before any action proceeds implies the public is not prepared to accept any environmental risk, no matter what economic or social benefits may arise (Peterson, 2006). At the extreme, such a requirement could involve bans and prohibitions on entire classes of potentially threatening activities or substances (Cooney, 2005). Over time, there has been a gradual transformation of the precautionary principle from what appears in the Rio Declaration to a stronger form that arguably [by whom] acts as restraint on development in the absence of firm evidence that it will do no harm.

International agreements and declarations

"Principle" vs. "approach"

No introduction to the precautionary principle would be complete without brief reference to the difference between the precautionary principle and the precautionary approach. Principle 15 of the Rio Declaration 1992 states that: "in order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall be not used as a reason for postponing cost-effective measures to prevent environmental degradation." As Garcia (1995) pointed out, "the wording, largely similar to that of the principle, is subtly different in that: it recognizes that there may be differences in local capabilities to apply the approach, and it calls for cost-effectiveness in applying the approach, e.g., taking economic and social costs into account." The "approach" is generally considered a softening of the "principle".

"As Recuerda has noted, the distinction between the precautionary principle and a precautionary approach is diffuse and, in some contexts, controversial. In the negotiations of international declarations, the United States has opposed the use of the term principle because this term has special connotations in legal language, due to the fact that a principle of law is a source of law. This means that it is compulsory, so a court can quash or confirm a decision through the application of the precautionary principle. In this sense, the precautionary principle is not a simple idea or a desideratum but a source of law. This is the legal status of the precautionary principle in the European Union. On the other hand, an 'approach' usually does not have the same meaning, although in some particular cases an approach could be binding. A precautionary approach is a particular "lens" used to identify risk that every prudent person possesses (Recuerda, 2008).

European Union

On 2 February 2000, the European Commission issued a Communication on the precautionary principle, in which it adopted a procedure for the application of this concept, but without giving a detailed definition of it. Paragraph 2 of article 191 of the Lisbon Treaty states that

Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

After the adoption of the European Commission's communication on the precautionary principle, the principle has come to inform much EU policy, including areas beyond environmental policy. As of 2006 it had been integrated into EU laws "in matters such as general product safety, the use of additives for use in animal nutrition, the incineration of waste, and the regulation of genetically modified organisms". Through its application in case law, it has become a "general principle of EU law".

In Case T-74/00 Artegodan, the General Court (then Court of First Instance) appeared willing to extrapolate from the limited provision for the precautionary principle in environmental policy in article 191(2) TFEU to a general principle of EU law.

France

In France, the Charter for the Environment contains a formulation of the precautionary principle (article 5):

When the occurrence of any damage, albeit unpredictable in the current state of scientific knowledge, may seriously and irreversibly harm the environment, public authorities shall, with due respect for the principle of precaution and the areas within their jurisdiction, ensure the implementation of procedures for risk assessment and the adoption of temporary measures commensurate with the risk involved in order to preclude the occurrence of such damage.

United States

On 18 July 2005, the City of San Francisco passed a precautionary principle purchasing ordinance, which requires the city to weigh the environmental and health costs of its $600 million in annual purchases – for everything from cleaning supplies to computers. Members of the Bay Area Working Group on the Precautionary Principle contributed to drafting the Ordinance.

Australia

The most important Australian court case so far, due to its exceptionally detailed consideration of the precautionary principle, is Telstra Corporation Limited v Hornsby Shire Council.

The principle was summarised by reference to the NSW Protection of the Environment Administration Act 1991, which itself provides a good definition of the principle:

"If there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reasoning for postponing measures to prevent environmental degradation. In the application of the principle... decisions should be guided by: (i) careful evaluation to avoid, wherever practicable, serious or irreversible damage to the environment; and (ii) an assessment of risk-weighted consequence of various options".

The most significant points of Justice Preston's decision are the following findings:

• The principle and accompanying need to take precautionary measures is "triggered" when two prior conditions exist: a threat of serious or irreversible damage, and scientific uncertainty as to the extent of possible damage.
• Once both are satisfied, "a proportionate precautionary measure may be taken to avert the anticipated threat of environmental damage, but it should be proportionate."
• The threat of serious or irreversible damage should invoke consideration of five factors: the scale of threat (local, regional etc.); the perceived value of the threatened environment; whether the possible impacts are manageable; the level of public concern, and whether there is a rational or scientific basis for the concern.
• The consideration of the level of scientific uncertainty should involve factors which may include: what would constitute sufficient evidence; the level and kind of uncertainty; and the potential to reduce uncertainty.
• The principle shifts the burden of proof. If the principle applies, the burden shifts: "a decision maker must assume the threat of serious or irreversible environmental damage is... a reality [and] the burden of showing this threat... is negligible reverts to the proponent..."
• The precautionary principle invokes preventative action: "the principle permits the taking of preventative measures without having to wait until the reality and seriousness of the threat become fully known".
• "The precautionary principle should not be used to try to avoid all risks."
• The precautionary measures appropriate will depend on the combined effect of "the degree of seriousness and irreversibility of the threat and the degree of uncertainty... the more significant and uncertain the threat, the greater...the precaution required". "...measures should be adopted... proportionate to the potential threats".

Philippines

A petition filed 17 May 2013 by environmental group Greenpeace Southeast Asia and farmer-scientist coalition Masipag (Magsasaka at Siyentipiko sa Pagpapaunlad ng Agrikultura) asked the appellate court to stop the planting of Bt eggplant in test fields, saying the impacts of such an undertaking to the environment, native crops and human health are still unknown. The Court of Appeals granted the petition, citing the precautionary principle stating "when human activities may lead to threats of serious and irreversible damage to the environment that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish the threat." Respondents filed a motion for reconsideration in June 2013 and on 20 September 2013 the Court of Appeals chose to uphold their May decision saying the bt talong field trials violate the people's constitutional right to a "balanced and healthful ecology." The Supreme Court on 8 December 2015 permanently stopped the field testing for Bt (Bacillus thuringiensis) talong (eggplant), upholding the decision of the Court of Appeals which stopped the field trials for the genetically modified eggplant. The court is the first in the world to adopt the precautionary principle regarding GMO products in its decision. The Supreme Court decision was later reversed following an appeal by researchers at the University of the Philippines Los Baños.

Corporate

Body Shop International, a UK-based cosmetics company, included the precautionary principle in their 2006 chemicals strategy.

Environment and health

Fields typically concerned by the precautionary principle are the possibility of:

• Global warming or abrupt climate change in general
• Extinction of species
• Introduction of new products into the environment, with potential impact on biodiversity (e.g., genetically modified organisms)
• Threats to public health, due to new diseases and techniques (e.g., HIV transmitted through blood transfusion)
• Long-term effects of new technologies (e.g. health concerns regarding radiation from cell phones and other electronics communications devices)
• Persistent or acute pollution (e.g., asbestos, endocrine disruptors)
• Food safety (e.g., Creutzfeldt–Jakob disease)
• Other new biosafety issues (e.g., artificial life, new molecules)

The precautionary principle is often applied to biological fields because changes cannot be easily contained and have the potential of being global. The principle has less relevance to contained fields such as aeronautics, where the few people undergoing risk have given informed consent (e.g., a test pilot). In the case of technological innovation, containment of impact tends to be more difficult if that technology can self-replicate. Bill Joy emphasised the dangers of replicating genetic technology, nanotechnology, and robotic technology in his article in Wired, "Why the future doesn't need us", though he does not specifically cite the precautionary principle. The application of the principle can be seen in the public policy of requiring pharmaceutical companies to carry out clinical trials to show that new medications are safe.

Oxford based philosopher Nick Bostrom discusses the idea of a future powerful superintelligence, and the risks should it attempt to gain atomic level control of matter.

Application of the principle modifies the status of innovation and risk assessment: it is not the risk that must be avoided or amended, but a potential risk that must be prevented. Thus, in the case of regulation of scientific research, there is a third party beyond the scientist and the regulator: the consumer.

In an analysis concerning application of the precautionary principle to nanotechnology, Chris Phoenix and Mike Treder posit that there are two forms of the principle, which they call the "strict form" and the "active form". The former "requires inaction when action might pose a risk", while the latter means "choosing less risky alternatives when they are available, and [...] taking responsibility for potential risks." Thomas Alured Faunce has argued for stronger application of the precautionary principle by chemical and health technology regulators particularly in relation to Ti0₂ and ZnO nanoparticles in sunscreens, biocidal nanosilver in waterways and products whose manufacture, handling or recycling exposes humans to the risk of inhaling multi-walled carbon nanotubes.

Resource management

The traffic light colour convention, showing the concept of harvest control rule (HCR), specifying when a rebuilding plan is mandatory in terms of precautionary and limit reference points for spawning biomass and fishing mortality rate.

Several natural resources like fish stocks are now managed by precautionary approach, through harvest control rules (HCRs) based upon the precautionary principle. The figure indicates how the principle is implemented in the cod fisheries management proposed by the International Council for the Exploration of the Sea.

In classifying endangered species, the precautionary principle means that if there is doubt about an animal's or plant's exact conservation status, the one that would cause the strongest protective measures to be realised should be chosen. Thus, a species like the silvery pigeon that might exist in considerable numbers and simply be under-recorded or might just as probably be long extinct is not classified as "data deficient" or "extinct" (which both do not require any protective action to be taken), but as "critically endangered" (the conservation status that confers the need for the strongest protection), whereas the increasingly rare, but probably not yet endangered emerald starling is classified as "data deficient", because there is urgent need for research to clarify its status rather than for conservation action to save it from extinction.

If, for example, a large ground-water body that people use for drinking water is contaminated by bacteria (e.g. Escherichia coli O157:H7, Campylobacter or Leptospira) and the source of contamination is strongly suspected to be dairy cows but the exact science is not yet able to provide absolute proof, the cows should be removed from the environment until they are proved, by the dairy industry, not to be the source or until that industry ensures that such contamination will not recur.

Animal sentience precautionary principle

See also: Ethics of uncertain sentience

Appeals to the precautionary principle have often characterized the debates concerning animal sentience – that is, the question of whether animals are able to feel "subjective experiences with an attractive or aversive quality", such as pain, pleasure, happiness, or joy – in relation to the question of whether we should legally protect sentient animals. A version of the precautionary principle suitable for the problem of animal sentience has been proposed by LSE philosopher Jonathan Birch: "The idea is that when the evidence of sentience is inconclusive, we should 'give the animal the benefit of doubt' or 'err on the side of caution' in formulating animal protection legislation." Since we cannot reach absolute certainty with regards to the fact that some animals are sentient, the precautionary principle has been invoked in order to grant potentially sentient animals "basic legal protections". Birch's formulation of the animal sentience precautionary principle runs as follows:

Where there are threats of serious, negative animal welfare outcomes, lack of full scientific certainty as to the sentience of the animals in question shall not be used as a reason for postponing cost-effective measures to prevent those outcomes.

This version of the precautionary principle consists of an epistemic and a decision rule. The former concerns the "evidential bar" that should be required for animal sentience. In other words, how much evidence of sentience is necessary before one decides to apply precautionary measures? According to Birch, only some evidence would be sufficient, which means that the evidential bar should be set at low levels. Birch proposes to consider the evidence that certain animals are sentient sufficient whenever "statistically significant evidence ... of the presence of at least one credible indicator of sentience in at least one species of that order" has been obtained. For practical reasons, Birch says, the evidence of sentience should concern the order, so that if one species meets the conditions of sentience, then all the species of the same order should be considered sentient and should be thus legally protected. This is due to the fact that, on the one hand, "to investigate sentience separately in different orders" is feasible, whereas on the other hand, since some orders include thousands of species, it would be unfeasible to study their sentience separately.

What is more, the evidential bar should be so low that only one indicator of sentience in the species of a specific order will be sufficient in order for the precautionary principle to be applied. Such indicator should be "an observable phenomenon that experiments can be designed to detect, and it must be credible that the presence of this indicator is explained by sentience". Lists of such criteria already exist for detecting animal pain. The aim is to create analogous lists for other criteria of sentience, such as happiness, fear, or joy. The presence of one of these criteria should be demonstrated by means of experiments which must meet "the normal scientific standards".

Regarding the second part of the animal sentience precautionary principle, the decision rule concerns the requirement that we have to act once there is sufficient evidence of a seriously bad outcome. According to Birch, "we should aim to include within the scope of animal protection legislation all animals for which the evidence of sentience is sufficient, according to the standard of sufficiency outlined [above]". In other words, the decision rule states that once the aforementioned low evidential bar is met, then we should act in a precautionary way. Birch's proposal also "deliberately leaves open the question of how, and to what extent, the treatment of these animals should be regulated", thus also leaving open the content of the regulations, as this will largely depend on the animal in question.

Criticisms

Critics of the principle use arguments similar to those against other formulations of technological conservatism.

Internal inconsistency: applying strong PP risks causing harm

Strong formulations of the precautionary principle, without regard to its most basic provisions (i.e., that it is to be applied only where risks are potentially catastrophic and not easily calculable), when applied to the principle itself as a policy decision, beats its own purpose of reducing risk. The reason suggested is that preventing innovation from coming to market means that only current technology may be used, and current technology itself may cause harm or leave needs unmet; there is a risk of causing harm by blocking innovation. As Michael Crichton wrote in his novel State of Fear: "The 'precautionary principle', properly applied, forbids the precautionary principle."

For example, forbidding nuclear power plants based on concerns about low-probability high-impact risks means continuing to rely on power plants that burn fossil fuels, which continue to release greenhouse gases and thousands of certain deaths from air pollution.

In 2021 in response to early reports about rare blood clots seen in 25 patients out of 20 million vaccinated by Astra-Zeneca COVID-19 vaccine a number of European Union member states suspended the use of the vaccine, quoting the "precautionary principle". This was criticized by other EU states who refused to suspend the vaccination program, declaring that the "precautionary" decisions are focusing on the wrong risk, as delay in a vaccination program results in a larger number of certain deaths than any yet unconfirmed complications.

Main article: European Commission–AstraZeneca COVID-19 vaccine dispute

In another example, the Hazardous Air Pollutant provisions in the 1990 amendments to the US Clean Air Act are an example of the Precautionary Principle where the onus is now on showing a listed compound is harmless. Under this rule no distinction is made between those air pollutants that provide a higher or lower risk, so operators tend to choose less-examined agents that are not on the existing list.

The very basis of the Precautionary Principle is to imagine the worst without supporting evidence... those with the darkest imaginations become the most influential.

— Adam Curtis, The Power of Nightmares

Blocking innovation and progress generally

See also: Fear, uncertainty and doubt

Because applications of strong formulations of the precautionary principle can be used to block innovation, a technology which brings advantages may be banned by precautionary principle because of its potential for negative impacts, leaving the positive benefits unrealised.

The precautionary principle has been ethically questioned on the basis that its application could block progress in developing countries.

The precautionary principle presents a serious hazard to our health which extends way beyond the generation of unnecessary neuroses. The biggest correlate of our health and well being is our standard of living, as measured in conventional economic and physical terms. People in technologically advanced societies suffer fewer diseases and live longer than those in less developed nations. The biggest killer in the world is not genetically modified soya, pesticide residues or even tobacco. It is something which is given the code Z59.5 in the International Classification of Disease Handbook and accounts for more deaths world-wide than any other single factor. It is defined as 'Extreme Poverty'.

— Social Issues Research Centre

Vagueness and plausibility

The precautionary principle calls for action in the face of scientific uncertainty, but some formulations do not specify the minimal threshold of plausibility of risk that acts as a "triggering" condition, so that any indication that a proposed product or activity might harm health or the environment is sufficient to invoke the principle. In Sancho vs. DOE, Helen Gillmor, Senior District Judge, wrote in a dismissal of Wagner's lawsuit which included a popular worry that the LHC could cause "destruction of the earth" by a black hole:

Injury in fact requires some "credible threat of harm." Cent. Delta Water Agency v. United States, 306 F.3d 938, 950 (9th Cir. 2002). At most, Wagner has alleged that experiments at the Large Hadron Collider (the "Collider") have "potential adverse consequences." Speculative fear of future harm does not constitute an injury in fact sufficient to confer standing. Mayfield, 599 F.3d at 970.

The precautionary dilemma

The most commonly pressed objection to the precautionary principle ties together two of the above objections into the form of a dilemma. This maintains that, of the two available interpretations of the principle, neither are plausible: weak formulations (which hold that precaution in the face of uncertain harms is permissible) are trivial, while strong formulations (which hold that precaution in the face of uncertain harms is required) are incoherent. On the first horn of the dilemma Cass Sunstein states:

The weak versions of the Precautionary Principle state a truism—uncontroversial in principle and necessary in practice only to combat public confusion or the self-interested claims of private groups demanding unambiguous evidence of harm, which no rational society requires.

If all that the (weak) principle states is that it is permissible to act in a precautionary manner where there is a possible risk of harm, then it constitutes a trivial truism and thus fails to be useful.

If we formulate the principle in the stronger sense however, it looks like it rules out all courses of action, including the precautionary measures it is intended to advocate. This is because, if we stipulate that precaution is required in the face of uncertain harms, and precautionary measures also carry a risk of harm, the precautionary principle can both demand and prohibit action at the same time. The risk of a policy resulting in catastrophic harm is always possible. For example: prohibiting genetically modified crops risks significantly reduced food production; placing a moratorium on nuclear power risks an over-reliance on coal that could lead to more air pollution; implementing extreme measures to slow global warming risks impoverishment and bad health outcomes for some people. The strong version of the precautionary principle, in that "[i]t bans the very steps that it requires", thus fails to be coherent. As Sunstein states, it is not protective, it is "paralyzing".

Genetically modified maize

From Wikipedia, the free encyclopedia

https://en.wikipedia.org/wiki/Genetically_modified_maize 

 

Transgenic maize containing a gene from the bacteria Bacillus thuringiensis

Genetically modified maize (corn) is a genetically modified crop. Specific maize strains have been genetically engineered to express agriculturally-desirable traits, including resistance to pests and to herbicides. Maize strains with both traits are now in use in multiple countries. GM maize has also caused controversy with respect to possible health effects, impact on other insects and impact on other plants via gene flow. One strain, called Starlink, was approved only for animal feed in the US but was found in food, leading to a series of recalls starting in 2000.

Marketed products

Herbicide-resistant maize

Corn varieties resistant to glyphosate herbicides were first commercialized in 1996 by Monsanto, and are known as "Roundup Ready Corn". They tolerate the use of Roundup. Bayer CropScience developed "Liberty Link Corn" that is resistant to glufosinate. Pioneer Hi-Bred has developed and markets corn hybrids with tolerance to imidazoline herbicides under the trademark "Clearfield" – though in these hybrids, the herbicide-tolerance trait was bred using tissue culture selection and the chemical mutagen ethyl methanesulfonate, not genetic engineering. Consequently, the regulatory framework governing the approval of transgenic crops does not apply for Clearfield.

As of 2011, herbicide-resistant GM corn was grown in 14 countries. By 2012, 26 varieties of herbicide-resistant GM maize were authorised for import into the European Union, but such imports remain controversial. Cultivation of herbicide-resistant corn in the EU provides substantial farm-level benefits.

Insect-resistant corn

The European corn borer, Ostrinia nubilalis, destroys corn crops by burrowing into the stem, causing the plant to fall over.

Bt maize/corn

Bt maize/Bt corn is a variant of maize that has been genetically altered to express one or more proteins from the bacterium Bacillus thuringiensis including Delta endotoxins. The protein is poisonous to certain insect pests. Spores of the bacillus are widely used in organic gardening, although GM corn is not considered organic. The European corn borer causes about a billion dollars in damage to corn crops each year.

In recent years, traits have been added to ward off corn ear worms and root worms, the latter of which annually causes about a billion dollars in damages.

The Bt protein is expressed throughout the plant. When a vulnerable insect eats the Bt-containing plant, the protein is activated in its gut, which is alkaline. In the alkaline environment, the protein partially unfolds and is cut by other proteins, forming a toxin that paralyzes the insect's digestive system and forms holes in the gut wall. The insect stops eating within a few hours and eventually starves.

In 1996, the first GM maize producing a Bt Cry protein was approved, which killed the European corn borer and related species; subsequent Bt genes were introduced that killed corn rootworm larvae.

The Philippine Government has promoted Bt corn, hoping for insect resistance and higher yields.

Approved Bt genes include single and stacked (event names bracketed) configurations of: Cry1A.105 (MON89034), CryIAb (MON810), CryIF (1507), Cry2Ab (MON89034), Cry3Bb1 (MON863 and MON88017), Cry34Ab1 (59122), Cry35Ab1 (59122), mCry3A (MIR604), and Vip3A (MIR162), in both corn and cotton. Corn genetically modified to produce VIP was first approved in the US in 2010.

A 2018 study found that Bt-corn protected nearby fields of non-Bt corn and nearby vegetable crops, reducing the use of pesticides on those crops. Data from 1976-1996 (before Bt corn was widespread) was compared to data after it was adopted (1996-2016). They examined levels of the European corn borer and corn earworm. Their larvae eat a variety of crops, including peppers and green beans. Between 1992 and 2016, the amount of insecticide applied to New Jersey pepper fields decreased by 85 percent. Another factor was the introduction of more effective pesticides that were applied less often.

Sweet Corn

GM sweet corn varieties include "Attribute", the brand name for insect-resistant sweet corn developed by Syngenta and Performance Series insect-resistant sweet corn developed by Monsanto.

Cuba

While Cuba's agriculture is largely focused on organic production, as of 2010, the country had developed a variety of genetically modified corn that is resistant to the palomilla moth.

Drought-resistant maize

In 2013 Monsanto launched the first transgenic drought tolerance trait in a line of corn hybrids called DroughtGard. The MON 87460 trait is provided by the insertion of the cspB gene from the soil microbe Bacillus subtilis; it was approved by the USDA in 2011 and by China in 2013.

Health Safety

In regular corn crops, insects promote fungal colonization by creating "wounds," or holes, in corn kernels. These wounds are favored by fungal spores for germination, which subsequently leads to mycotoxin accumulation in the crop that can be carcinogenic and toxic to humans and other animals. This can prove to be especially devastating in developing countries with drastic climate patterns such as high temperatures, which favor the development of toxic fungi. In addition, higher mycotoxin levels leads to market rejection or reduced market prices for the grain. GM corn crops encounter fewer insect attacks, and thus, have lower concentrations of mycotoxins. Fewer insect attacks also keep corn ears from being damaged, which increases overall yields.

Products in development

In 2007, South African researchers announced the production of transgenic maize resistant to maize streak virus (MSV), although it has not been released as a product. While breeding cultivars for resistance to MSV isn't done in the public, the private sector, international research centers, and national programmes have done all of the breeding. As of 2014, there have been a few MSV-tolerant cultivars released in Africa. A private company Seedco has released 5 MSV cultivars.

Research has been done on adding a single E. coli gene to maize to enable it to be grown with an essential amino acid (methionine).

Refuges

US Environmental Protection Agency (EPA) regulations require farmers who plant Bt corn to plant non-Bt corn nearby (called a refuge) to provide a location to harbor vulnerable pests. Typically, 20% of corn in a grower's fields must be refuge; refuge must be at least 0.5 miles from Bt corn for lepidopteran pests, and refuge for corn rootworm must at least be adjacent to a Bt field.

The theory behind these refuges is to slow the evolution of resistance to the pesticide. EPA regulations also require seed companies to train farmers how to maintain refuges, to collect data on the refuges and to report that data to the EPA. A study of these reports found that from 2003 to 2005 farmer compliance with keeping refuges was above 90%, but that by 2008 approximately 25% of Bt corn farmers did not keep refuges properly, raising concerns that resistance would develop.

Unmodified crops received most of the economic benefits of Bt corn in the US in 1996–2007, because of the overall reduction of pest populations. This reduction came because females laid eggs on modified and unmodified strains alike.

Seed bags containing both Bt and refuge seed have been approved by the EPA in the United States. These seed mixtures were marketed as "Refuge in a Bag" (RIB) to increase farmer compliance with refuge requirements and reduce additional work needed at planting from having separate Bt and refuge seed bags on hand. The EPA approved a lower percentage of refuge seed in these seed mixtures ranging from 5 to 10%. This strategy is likely to reduce the likelihood of Bt-resistance occurring for corn rootworm, but may increase the risk of resistance for lepidopteran pests, such as European corn borer. Increased concerns for resistance with seed mixtures include partially resistant larvae on a Bt plant being able to move to a susceptible plant to survive or cross pollination of refuge pollen on to Bt plants that can lower the amount of Bt expressed in kernels for ear feeding insects.

Resistance

Resistant strains of the European corn borer have developed in areas with defective or absent refuge management.

In November 2009, Monsanto scientists found the pink bollworm had become resistant to first-generation Bt cotton in parts of Gujarat, India – that generation expresses one Bt gene, Cry1Ac. This was the first instance of Bt resistance confirmed by Monsanto anywhere in the world. Bollworm resistance to first generation Bt cotton has been identified in Australia, China, Spain, and the United States. In 2012, a Florida field trial demonstrated that army worms were resistant to pesticide-containing GM corn produced by Dupont-Dow; armyworm resistance was first discovered in Puerto Rico in 2006, prompting Dow and DuPont to voluntarily stop selling the product on the island.

Regulation

Main article: Regulation of the release of genetic modified organisms

Regulation of GM crops varies between countries, with some of the most-marked differences occurring between the US and Europe. Regulation varies in a given country depending on intended uses.

Controversy

Main article: Genetically modified food controversies

There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.

The scientific rigor of the studies regarding human health has been disputed due to alleged lack of independence and due to conflicts of interest involving governing bodies and some of those who perform and evaluate the studies. However, no reports of ill effects from GM food have been documented in the human population.

GM crops provide a number of ecological benefits, but there are also concerns for their overuse, stalled research outside of the Bt seed industry, proper management and issues with Bt resistance arising from their misuse.

Critics have objected to GM crops on ecological, economic and health grounds. The economic issues derive from those organisms that are subject to intellectual property law, mostly patents. The first generation of GM crops lose patent protection beginning in 2015. Monsanto has claimed it will not pursue farmers who retain seeds of off-patent varieties. These controversies have led to litigation, international trade disputes, protests and to restrictive legislation in most countries.

Introduction of Bt maize led to significant reduction of mycotoxin-related poisoning and cancer rates, as they were significantly less prone to contain mycotoxins (29%), fumonisins (31%) and thricotecens (37%), all of which are toxic and carcinogenic.

Effects on nontarget insects

Critics claim that Bt proteins could target predatory and other beneficial or harmless insects as well as the targeted pest. These proteins have been used as organic sprays for insect control in France since 1938 and the USA since 1958 with no ill effects on the environment reported. While cyt proteins are toxic towards the insect order Diptera (flies), certain cry proteins selectively target lepidopterans (moths and butterflies), while other cyt selectively target Coleoptera. As a toxic mechanism, cry proteins bind to specific receptors on the membranes of mid-gut (epithelial) cells, resulting in rupture of those cells. Any organism that lacks the appropriate gut receptors cannot be affected by the cry protein, and therefore Bt. Regulatory agencies assess the potential for the transgenic plant to impact nontarget organisms before approving commercial release.

A 1999 study found that in a lab environment, pollen from Bt maize dusted onto milkweed could harm the monarch butterfly. Several groups later studied the phenomenon in both the field and the laboratory, resulting in a risk assessment that concluded that any risk posed by the corn to butterfly populations under real-world conditions was negligible. A 2002 review of the scientific literature concluded that "the commercial large-scale cultivation of current Bt–maize hybrids did not pose a significant risk to the monarch population". A 2007 review found that "nontarget invertebrates are generally more abundant in Bt cotton and Bt maize fields than in nontransgenic fields managed with insecticides. However, in comparison with insecticide-free control fields, certain nontarget taxa are less abundant in Bt fields."

Gene flow

Gene flow is the transfer of genes and/or alleles from one species to another. Concerns focus on the interaction between GM and other maize varieties in Mexico, and of gene flow into refuges.

In 2009 the government of Mexico created a regulatory pathway for genetically modified maize, but because Mexico is the center of diversity for maize, gene flow could affect a large fraction of the world's maize strains. A 2001 report in Nature presented evidence that Bt maize was cross-breeding with unmodified maize in Mexico. The data in this paper was later described as originating from an artifact. Nature later stated, "the evidence available is not sufficient to justify the publication of the original paper". A 2005 large-scale study failed to find any evidence of contamination in Oaxaca. However, other authors also found evidence of cross-breeding between natural maize and transgenic maize.

A 2004 study found Bt protein in kernels of refuge corn.

In 2017, a large-scale study found "pervasive presence of transgenes and glyphosate in maize-derived food in Mexico"

Food

The French High Council of Biotechnologies Scientific Committee reviewed the 2009 Vendômois et al. study and concluded that it "presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." However, the French government applies the precautionary principle with respect to GMOs.

A review by Food Standards Australia New Zealand and others of the same study concluded that the results were due to chance alone.

A 2011 Canadian study looked at the presence of CryAb1 protein (BT toxin) in non-pregnant women, pregnant women and fetal blood. All groups had detectable levels of the protein, including 93% of pregnant women and 80% of fetuses at concentrations of 0.19 ± 0.30 and 0.04 ± 0.04 mean ± SD ng/ml, respectively. The paper did not discuss safety implications or find any health problems. FSANZ agency published a comment pointing out a number of inconsistencies in the paper, most notably that it "does not provide any evidence that GM foods are the source of the protein".

In January 2013, the European Food Safety Authority released all data submitted by Monsanto in relation to the 2003 authorisation of maize genetically modified for glyphosate tolerance.

Starlink corn recalls

Main article: Starlink corn recall

StarLink contains Cry9C, which had not previously been used in a GM crop. Starlink's creator, Plant Genetic Systems, had applied to the US Environmental Protection Agency (EPA) to market Starlink for use in animal feed and in human food. However, because the Cry9C protein lasts longer in the digestive system than other Bt proteins, the EPA had concerns about its allergenicity, and PGS did not provide sufficient data to prove that Cry9C was not allergenic. As a result, PGS split its application into separate permits for use in food and use in animal feed. Starlink was approved by the EPA for use in animal feed only in May 1998.

StarLink corn was subsequently found in food destined for consumption by humans in the US, Japan, and South Korea. This corn became the subject of the widely publicized Starlink corn recall, which started when Taco Bell-branded taco shells sold in supermarkets were found to contain the corn. Sales of StarLink seed were discontinued. The registration for Starlink varieties was voluntarily withdrawn by Aventis in October 2000. Pioneer had been bought by AgrEvo which then became Aventis CropScience at the time of the incident, which was later bought by Bayer.

Fifty-one people reported adverse effects to the FDA; US Centers for Disease Control (CDC), which determined that 28 of them were possibly related to Starlink. However, the CDC studied the blood of these 28 individuals and concluded there was no evidence of hypersensitivity to the Starlink Bt protein.

A subsequent review of these tests by the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel points out that while "the negative results decrease the probability that the Cry9C protein is the cause of allergic symptoms in the individuals examined ... in the absence of a positive control and questions regarding the sensitivity and specificity of the assay, it is not possible to assign a negative predictive value to this."

The US corn supply has been monitored for the presence of the Starlink Bt proteins since 2001.

In 2005, aid sent by the UN and the US to Central American nations also contained some StarLink corn. The nations involved, Nicaragua, Honduras, El Salvador and Guatemala refused to accept the aid.

Corporate espionage

On 19 December 2013 six Chinese citizens were indicted in Iowa on charges of plotting to steal genetically modified seeds worth tens of millions of dollars from Monsanto and DuPont. Mo Hailong, director of international business at the Beijing Dabeinong Technology Group Co., part of the Beijing-based DBN Group, was accused of stealing trade secrets after he was found digging in an Iowa cornfield.