Sunday, October 18, 2015

The Roundup Controversy Examined Further

[Health and Medicine]

There has been increasing controversy over the herbicide Roundup which has been in use for weed control in agriculture, commercial and residential applications for the past 40 years.

Monsanto invented the herbicide glyphosate and brought it to market under the trade name Roundup in 1974, after DDT was banned. But it wasn’t until the late 1990s that the use of Roundup surged, thanks to Monsanto’s ingenious marketing strategy - Genetically engineering seeds to grow food crops that could tolerate high doses of Roundup. With the introduction of these new GE seeds, farmers could now easily control weeds on their corn, soy, cotton, canola, sugar beets and alfalfa crops—crops that thrived while the weeds around them were wiped out by Roundup.

Eager to sell more of its flagship herbicide, Monsanto also encouraged farmers to use Roundup as a desiccant, to dry out all of their crops so they could harvest them faster. So Roundup is now routinely sprayed directly on a host of non-GMO crops, including wheat, barley, oats, canola, flax, peas, lentils, soybeans, dry beans and sugar cane.

Between 1996 – 2011, the widespread use of Roundup Ready GMO crops increased herbicide use in the U.S. by 527 million pounds—even though Monsanto claimed its GMO crops would reduce pesticide and herbicide use.

Let’ take a look at the some of the pro and con arguments.

Pro Arguments

Monsanto, Roundup’s manufacturer, contends that the methods used in studies, such as Séralini's, don’t reflect realistic conditions and that their product, which has been sold since the 1970s, is safe when used as directed. Hundreds of studies over the past 35 years have addressed the safety of glyphosate.

“Roundup has one of the most extensive human health safety and environmental data packages of any pesticide that's out there,” said Monsanto spokesman John Combest. “It's used in public parks, it's used to protect schools. There's been a great deal of study on Roundup, and we're very proud of its performance.”

The EPA considers glyphosate to have low toxicity when used at the recommended doses.

“Risk estimates for glyphosate were well below the level of concern,” said EPA spokesman Dale Kemery. The EPA classifies glyphosate as a Group E chemical, which means there is strong evidence that it does not cause cancer in humans.

In fact, the NIH (National Institute of Health) proposes that while recognizing the adjuvant properties of various formulations, and expressly noting the effects of POEA, that toxicity studies are inconclusive. “Experimental studies suggest that the toxicity of the surfactant, polyoxyethyleneamine (POEA), is greater than the toxicity of glyphosate alone and commercial formulations alone. There is insufficient evidence to conclude that glyphosate preparations containing POEA are more toxic than those containing alternative surfactants. Although surfactants probably contribute to the acute toxicity of glyphosate formulations, the weight of evidence is against surfactants potentiating the toxicity of glyphosate. “

In addition, the EPA and the U.S. Department of Agriculture both recognize POEA as an inert ingredient. Derived from animal fat, POEA is allowed in products certified organic by the USDA. The EPA has concluded that it is not dangerous to public health or the environment.

What more evidence do you need regarding the safety of Roundup, glyphosate and POEA, than the findings of our various governmental agencies such as the EPA, FDA, USDA and the NIH?  Well, that is why this is so controversial, as there are many other findings presented via independent studies that merit our consideration.

Con Arguments

Glyphosate, Roundup’s active ingredient, is the most widely used herbicide in the US.  About 100 million pounds are applied to US farms and lawns every year, according to the EPA. However, until more recently, most health studies have focused on the safety of glyphosate, rather than the mixture of ingredients found in Roundup. But in these new studies, scientists found that Roundup’s inert ingredients significantly amplified the toxic effect on human cells—even at concentrations much more diluted than those used on farms and lawns.

Glyphosate has been safety tested on mammals for the purposes of regulatory risk assessment. But the commercial formulations of these pesticides as they are sold and used contain added ingredients (adjuvants). These are often classified confidential and described as “inerts”. However, they help to stabilize the chemical compound glyphosate and help it to penetrate plants, in the manner of corrosive detergents.

The formulated herbicides (including Roundup) can affect all living cells, especially human cells. This danger is overlooked because glyphosate and Roundup are treated as the same by industry and regulators on long-term studies. The supposed non-toxicity of glyphosate serves as a basis for the commercial release of Roundup. The health and environmental agencies and pesticide companies assess the long-term effects on mammals of glyphosate alone, and not the full formulation. The details of this regulatory assessment are kept confidential by companies like Monsanto and health and environmental agencies.

One specific inert ingredient, polyethoxylated tallowamine, or POEA, was more deadly to human embryonic, placental and umbilical cord cells than the herbicide itself – a finding the researchers call “astonishing.”

“This clearly confirms that the [inert ingredients] in Roundup formulations are not inert,” wrote the authors of one study from France’s University of Caen. “Moreover, the proprietary mixtures available on the market could cause cell damage and even death [at the] residual levels” found on Roundup-treated crops, such as soybeans, alfalfa and corn, or lawns and gardens.

The researchers suspect that Roundup might cause pregnancy problems by interfering with hormone production, possibly leading to abnormal fetal development, low birth weights or miscarriages.

Working with plant biologists, we have learned that glyphosate kills weeds by turning off key enzymes that produce defense mechanisms for plants.  It essentially targets and destroys their immune systems by chelating, stripping, micronutrients like magnesium, copper and zinc from the plant.  As a result, there are fewer of these key micronutrients in the plants and in our food supply.

This effect, according to the researchers, can contribute to causing or worsening “…most of the diseases and conditions associated with a Western diet which include gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer and Alzheimer’s disease.”

Furthermore, this issue is more complicated than the straightforward toxicity to human cells. While Monsanto insists that Roundup is as safe to humans as aspirin, Seneff and Samsel's research tells a different story altogether. Their report, published in the journal Entropy, argues that glyphosate residues, found in most commonly consumed foods in the Western diet courtesy of GE sugar, corn, soy and wheat, "enhance the damaging effects of other food-born chemical residues and toxins in the environment to disrupt normal body functions and induce disease."

Interestingly, your gut bacteria are a key component of glyphosate's mechanism of harm.
Monsanto has steadfastly claimed that Roundup is harmless to animals and humans because the mechanism of action it uses (which allows it to kill weeds), called the shikimate pathway, is absent in all animals. However, the shikimate pathway IS present in bacteria, and that's the key to understanding how it causes such widespread systemic harm in both humans and animals.

The bacteria in your body outnumber your cells by 10 to 1. For every cell in your body, you have 10 microbes of various kinds, and all of them have the shikimate pathway, so they will all respond to the presence of glyphosate!

Glyphosate causes extreme disruption of the microbe's function and lifecycle. What's worse, glyphosate preferentially affects beneficial bacteria, allowing pathogens to overgrow and take over. At that point, your body also has to contend with the toxins produced by the pathogens. Once the chronic inflammation sets in, you're well on your way toward chronic and potentially debilitating disease.

Here is a list of health issues that are currently correlated with Roundup and/or glyphosate:
  • ADHD: In farming communities, there’s a strong correlation between Roundup exposure and attention deficit disorder (ADHD), likely due to glyphosate’s capacity to disrupt thyroid hormone functions.
  • Alzheimer’s disease: In the lab, Roundup causes the same type of oxidative stress and neural cell death observed in Alzheimer’s disease. And it affects CaMKII, an enzyme whose deregulation has also been linked to the disease.
  • Anencephaly (birth defect): An investigation into neural tube defects among babies born to women living within 1,000 meters of pesticide applications showed an association for glyphosate with anencephaly, the absence of a major portion of the brain, skull and scalp that forms during embryonic development.
  • Autism: Glyphosate has a number of known biological effects that align with the known pathologies associated with autism. One of these parallels is the gut dysbiosis observed in autistic children and the toxicity of glyphosate to beneficial bacteria that suppress pathogenic bacteria, along with pathogenic bacteria’s high resistance to glyphosate. In addition, glyphosate’s capacity to promote aluminum accumulation in the brain may make it the principal cause of autism in the U.S.
  • Birth defects: Roundup and glyphosate can disrupt the Vitamin A (retinoic acid) signaling pathway, which is crucial for normal fetal development. The babies of women living within one kilometer of fields sprayed with glyphosate were more than twice as likely to have birth defects according to a study from Paraguay. Congenital defects quadrupled in the decade after Roundup Ready crops arrived in Chaco, a province in Argentina where glyphosate is used roughly eight to ten times more per acre than in the U.S. A study of one farming family in the U.S. documented elevated levels of glyphosate and birth defects in the children, including an imperforate anus, growth hormone deficiency, hypospadias (an abnormally placed urinary hole), a heart defect and a micro penis.
  • Brain cancer: In a study of children with brain cancer compared with healthy children, researchers found that if either parent had been exposed to Roundup during the two years before the child’s birth, the chances of the child developing brain cancer doubled.
  • Breast cancer: Glyphosate induces human breast cancer cells growth via estrogen receptors. The only long-term animal study of glyphosate exposure produced rats with mammary tumors and shortened life-spans.
  • Cancer: House-to-house surveys of 65,000 people in farming communities in Argentina where Roundup is used, known there as the fumigated towns, found cancer rates two to four times higher than the national average, with increases in breast, prostate and lung cancers. In a comparison of two villages, in the one where Roundup was sprayed, 31 percent of residents had a family member with cancer, while only 3 percent of residents in a ranching village without spraying had one. The high cancer rates among people exposed to Roundup likely stem from glyphosate’s known capacity to induce DNA damage, which has been demonstrated in numerous lab tests.
  • Celiac disease and gluten intolerance: Fish exposed to glyphosate develop digestive problems that are reminiscent of celiac disease. There are parallels between the characteristics of celiac disease and the known effects of glyphosate. These include imbalances in gut bacteria, impairment in enzymes involved with detoxifying environmental toxins, mineral deficiencies and amino acid depletion.
  • Chronic kidney disease: Increases in the use of glyphosate may explain the recent surge in kidney failure among agricultural workers in Central America, Sri Lanka and India. Scientists have concluded, “Although glyphosate alone does not cause an epidemic of chronic kidney disease, it seems to have acquired the ability to destroy the renal tissues of thousands of farmers when it forms complexes with [hard water] and nephrotoxic metals.”
  • Colitis: The toxicity of glyphosate to beneficial bacteria that suppress clostridia, along with clostridia’s high resistance to glyphosate, could be a significant predisposing factor in the overgrowth of clostridia. Overgrowth of clostridia, specifically C. difficile, is a well-established causal factor in colitis.
  • Depression: Glyphosate disrupts chemical processes that impact the production of serotonin, an important neurotransmitter that regulates mood, appetite and sleep. Serotonin impairment has been linked to depression.
  • Diabetes: Low levels of testosterone are a risk factor for Type 2 diabetes. Rats fed environmentally relevant doses of Roundup over a period of 30 days spanning the onset of puberty had reduced testosterone production sufficient to alter testicular cell morphology and to delay the onset of puberty.
  • Heart disease: Glyphosate can disrupt the body’s enzymes, causing lysosomal dysfunction, a major factor in cardiovascular disease and heart failure.
  • Hypothyroidism: House-to-house surveys of 65,000 people in farming communities in Argentina where Roundup is used, known there as the fumigated towns, found higher rates of hypothyroidism.
  • Inflammatory Bowl Disease (“Leaky Gut Syndrome”): Glyphosate can induce severe tryptophan deficiency, which can lead to an extreme inflammatory bowel disease that severely impairs the ability to absorb nutrients through the gut, due to inflammation, bleeding and diarrhea.
  • Liver disease: Very low doses of Roundup can disrupt human liver cell function, according to a 2009 study published in Toxicology.
  • Lou Gehrig’s Disease (ALS): Sulfate deficiency in the brain has been associated with Amyotrophic Lateral Sclerosis (ALS). Glyphosate disrupts sulfate transport from the gut to the liver, and may lead over time to severe sulfate deficiency throughout all the tissues, including the brain.
  • Multiple Sclerosis (MS): An increased incidence of inflammatory bowel disease (IBS) has been found in association with MS. Glyphosate may be a causal factor. The hypothesis is that glyphosate-induced IBS causes gut bacteria to leak into the vasculature, triggering an immune reaction and consequently an autoimmune disorder resulting in destruction of the myelin sheath.
  • Non-Hodgkin lymphoma: A systematic review and a series of meta-analyses of nearly three decades worth of epidemiologic research on the relationship between non-Hodgkin lymphoma (NHL) and occupational exposure to agricultural pesticides found that B cell lymphoma was positively associated with glyphosate.
  • Parkinson’s disease: The brain-damaging effects of herbicides have been recognized as the main environmental factor associated with neurodegenerative disorders, including Parkinson’s disease. The onset of Parkinson’s following exposure to glyphosate has been well documented and lab studies show that glyphosate induces the cell death characteristic of the disease.
  • Pregnancy problems (infertility, miscarriages, stillbirths): Glyphosate is toxic to human placental cells, which, scientists say, explains the pregnancy problems of agricultural workers exposed to the herbicide.
  • Obesity: An experiment involving the transfer of a strain of endotoxin-producing bacteria from the gut of an obese human to the guts of mice caused the mice to become obese. Since glyphosate induces a shift in gut bacteria towards endotoxin-producers, glyphosate exposure may contribute to obesity in this way.
  • Reproductive problems: Studies of laboratory animals have found that male rats exposed to high levels of glyphosate, either during prenatal or pubertal development, suffer from reproductive problems, including delayed puberty, decreased sperm production, and decreased testosterone production.
  • Respiratory illnesses: House-to-house surveys of 65,000 people in farming communities in Argentina where Roundup is used, known there as the fumigated towns, found higher rates of chronic respiratory illnesses.
Net Results

Studies such as was recently conducted by Séralini at the University of Caen demonstrates that all the glyphosate-based herbicides tested are more toxic than glyphosate alone, and explains why. Thus glyphosate-based herbicide regulatory assessments and the maximum residue levels authorized in the environment, food, and feed, are erroneous. A drink (such as tap water contaminated by Roundup residues) or a food made with a Roundup tolerant GMO (like a transgenic soya or corn) were already demonstrated as toxic in the recent rat feeding study from Prof. Séralini team. The researchers have also published responses to critics of the study. This new research explains and confirms the scientific results of the rat feeding study.

Overall, it is a great matter of concern for public health. First, all authorizations of Roundup-type herbicides have to be questioned urgently. Second, the regulatory assessment rules have to be fully revised. They should be analyzed in a transparent and contradictory manner by the scientific community. Agencies that give opinions to government authorities, in common with the pesticide companies generally conclude safety. The agencies’ opinions are wrong because they are made on the basis of lax assessments and much of the industry data is kept confidential, meaning that a full and transparent assessment cannot be carried out. These assessments are therefore neither neutral nor independent. They should as a first step make public on the Internet all the data that underpin the commercial release and positive opinions on the use of Roundup and similar products. The industry toxicological data must be legally made public.

Adjuvants of the POE-15 family (polyethoxylated tallowamine) have now been revealed as actively toxic to human cells, and must be regulated as such. The complete formulations must be tested in long-term toxicity studies and the results taken into account in regulatory assessments. The regulatory authorization process for pesticides released into the environment and sold in stores must urgently be revised. Moreover, since the toxic confidential adjuvants are in general use in pesticide formulations, we fear according to these discoveries that the toxicity of all pesticides has been very significantly underestimated.


You still need to do your own research.  It was never more true than it is in this particular controversy, that you can find evidence to support whatever position you wish to take.  It does seem reasonable to require our governmental agencies to consider their methods for assessing the risks of chemical compounds such as Roundup, and to be more transparent, and to be more receptive to various external and independently performed studies.

The implications of herbicides such as Roundup, as they apply to agriculture, the environment and human health can not be properly understood when examined in a manner that is too narrowly focused, such as the analysis of glyphosate independent of the adjuvants that make up the rest of the formula.  Similarly, not considering a more holistic spectrum impacts, such as the pronounced effects on the beneficial microbes necessary for our overall health.  And lastly, we must overcome the persistent denial of the mounting evidence that correlates increases in specific illnesses with the increased application of Roundup, these correlation merit greater concern, research and response if we are truly interested in the health and well being of our citizens.

  1. Gammon, Crystal (Environmental Health News). "Weed-Whacking Herbicide Proves Deadly to Human Cells" Scientific American 23 June 2009
  2. SM, Bradberry; AT, Proudfoot; JA, Vale. "Glyphosate Poisoning" National Center for Biotechnology Information 2004
  3. Mesnage, Robin; Bernay Benoît; Séralini, Gilles-Eric. “Ethoxylated adjuvants of glyphosate-based herbicides are active principles of human cell toxicity” Toxicology 10 September 2012
  4. Baden-Mayer, Alexis. “15 Health Problems Linked to Monsanto’s Roundup” Organic Consumers Association 23 January 2015
  5. O’Brien, Robyn (Allergy Kids, founder). “MIT Study Questions Monsanto’s Safety Claims for RoundUp” Organic Connections 2013
  6. Dr. Mercola, Joseph. “Monsanto’s Roundup Herbicide May Be Most Important Factor in Development of Autism and Other Chronic Disease” 9 June 2013

Sunday, September 20, 2015

USDA, FDA, and EPA: How's That Working for You?

[Food and Technology, Business and Politics]

When I think about biotech in relation to our foods, both in regards to the genetically engineered products themselves and the chemical protocols that accompany them, I ponder the efficacy of our various governmental agencies overseeing and regulating this field – USDA, FDA and EPA. From there, I am reminded of a phrase used by the popularized TV personality psychologist Dr. Phil, “How’s that working for you?”  I think that is a question each of us should be asking ourselves.

When trying to understand what roles various governmental agencies have in the oversight and regulation of genetically engineered products, one can quickly find themselves going down the proverbial ‘rabbit hole’ while attempting to navigate our massive and complex regulatory system.  This article attempts to bring relevant detail forwards, yet also distill this information into some very simple points.

In the United States, when deciding whether or not a genetically engineered (GE) product is safe for the environment and for consumption, the primary regulating agencies involved are:
  • United States Department of Agriculture (USDA) – ensures that biotech products are safe for agriculture and the environment.
  • United States Environmental Protection Agency (EPA) – focuses primarily on chemicals use such insecticides and herbicides.
  • Food and Drug Administration (FDA) - centered on food and feed safety. Once called the Food, Drug and Insecticide Administration.
All three agencies (USDA, FDA, and EPA) overlap in their responsibilities, but each also has unique duties.

What follows is an overview of these three agencies in greater detail and primarily in the context of GE products including both production and consumption:

United States Department of Agriculture (USDA)

The USDA is a regulatory agency that monitors and regulates the use of biotechnology for agricultural purposes. They have the responsibility of reviewing data generated from field trials to determine whether a product or crop would have the potential to become a plant pest or cause any detrimental effects on the environment. Genetically engineered herbicide-tolerant crops are included in this because they do not actually produce a pesticide, which would be the responsibility of the EPA (discussed below). Instead, herbicide-tolerant crops are engineered to produce a protein which are resistant to a specific herbicide sprayed on them. An example of this is glyphosate-tolerant (e.g., Roundup Ready) soybean, corn, and canola.

The USDA is comprised of several agencies that are all designed to advise different groups to meet their specific needs. A relevant example is the Animal and Plant Health Inspection Agency (APHIS). The Animal and Plant Health Inspection Agency regulates the movement, importation, and field testing of genetically engineered organisms through permitting and notification procedures. APHIS also is responsible for inspecting veterinary biologics production. In fact, as just one agency within the USDA, APHIS has a very broad focus including:
  • Animal Health
  • Animal Welfare
  • Biotechnology Regulatory Services (BRS)
  • Marketing and Regulatory Programs Business Services (MRPBS)
  • Civil Rights
  • Emergency Response
  • Imports and Exports
  • International Services
  • Plant Health
  • Science Services
  • Tribal Relations
  • Wildlife Damage
To further illustrate how wide and deep this division of the USDA is, the APHIS’ scientific facilities include the:
•          Center for Plant Health Science and Technology, where scientists evaluate risks associated with the introduction of plant pests and develop methods to exclude, detect, and manage invasive plant pests and weeds;
•          Centers for Epidemiology and Animal Health, where multidisciplinary specialists track emerging animal health threats, monitor U.S. livestock management and production, design comprehensive animal health surveillance programs, and conduct risk assessments to identify situations that could impact the health of U.S. animal agriculture;
•          National Wildlife Research Center, the world’s only research center devoted entirely to the development of methods for effective wildlife damage management;
•          National Veterinary Services Laboratories (NVSL), the Nation’s premier animal health diagnostic laboratory and a World Animal Health Organization reference laboratory for animal diseases of importance to the Americas; 
•          Foreign Animal Disease Diagnostic Laboratory, a high-security biocontainment facility, part of the NVSL, where experts diagnose and develop tests for foreign animal diseases that threaten U.S. animal agriculture, as well as maintain forensic capabilities that can be used in the event of potential bioterrorist releases;
•          National Animal Health Laboratory Network, an extensive and integrated system of Federal, State, and university laboratories that provide animal disease diagnostic services in both routine and emergency situations, including bioterrorism events;
•          Center for Veterinary Biologics, the Nation’s sole laboratory involved in the testing and regulation of commercial veterinary biologics (vaccines and diagnostic kits) in the United States; and the
•          Center for Animal Welfare, where APHIS specialists collaborate with a diverse network of external partners and experts to serve as a national and international resource for animal welfare science, training, education, and policy strategy.

A few other agencies included within the USDA are the Forest Service, Risk Management Agency, and Agricultural Research Service.

The USDA APHIS unit that plays the most critical role in the evaluation and regulation of transgenic organisms is the office of Biotechnology Regulatory Services (BRS). In the regulation of genetically engineered organisms, BRS is critical part of a science-based federal regulatory framework to protect America's agricultural resources and the broader environment. The work of BRS is coordinated across four program divisions; Policy Coordination Programs, Biotechnology Risk Analysis Programs, Regulatory Operations Programs, and Resource Management Programs. Each program plays a unique role in accomplishing BRS goals.

Environmental Protection Agency (EPA)

The EPA’s mission is to protect the quality and health of the environment. In terms of protecting the environment from biotechnology products, their main focus is on the regulation of pest management products. There are three categories of pesticides the EPA reviews for registration. The three pesticide categories are antimicrobials, biopesticides, and conventional pesticides. Before a pesticide can be used, it has to be approved by the EPA to ensure that is it not harmful to humans or the environment. For this article, we will focus on the EPA’s role in regulating biopesticides, specifically Plant-Incorporated Protectants (PIPs). Biopesticides consist of biochemical pesticides, microbial pesticides, and PIPs. Plant-Incorporated Protectants are pesticidal substances produced by plants containing added genetic material. When regulating PIPs, the EPA regulates the new protein and its genetic material, not the plant itself.  However, it is worth noting that protocols accompanying some GE crops include the use of controversial chemicals such as various formulations containing glyphosate or 2,4-D.

Food and Drug Administration (FDA)

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Additionally, the FDA has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  Finally, the FDA plays a significant role in the Nation’s counterterrorism capability. They fulfill this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The following is a list of traditionally-recognized product categories that fall under the FDA’s regulatory jurisdiction; however, this is not an exhaustive list.  In general, the FDA regulates:
Foods, including:
•      dietary supplements
•      bottled water
•      food additives
•      infant formulas
•      other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
Biologics, including:
•      vaccines
•      blood and blood products
•      cellular and gene therapy products
•      tissue and tissue products
•      allergenics
Medical Devices, including:
•      simple items like tongue depressors and bedpans
•      complex technologies such as heart pacemakers
•      dental devices
•      surgical implants and prosthetics
Veterinary Products, including:
•      livestock feeds
•      pet foods
•      veterinary drugs and devices
Drugs, including:
•   prescription drugs (both brand-name and generic)
•   non-prescription (over-the-counter) drugs
Electronic Products that give off radiation, including:
•   microwave ovens
•   x-ray equipment
•   laser products
•   ultrasonic therapy equipment
•   mercury vapor lamps
•   sunlamps
Cosmetics, including:
•   color additives found in makeup and other personal care products
•   skin moisturizers and cleansers
•   nail polish and perfume
Tobacco Products, including:
•   cigarettes
•   cigarette tobacco
•   roll-your-own tobacco
•   smokeless tobacco

Biotech crops go through rigorous testing for several years before they are ever put on a farmer’s field. In the U.S., there are nine steps in the regulatory process that usually take seven to ten years to complete, which is a far more lengthy process than any conventionally derived food ever goes through. The USDA/APHIS is responsible for ensuring that any released organisms are safe and will not pose any negative effects on the environment, whereas the EPA evaluates the safety of transgenic plants containing PIPs. They consider where and how the protein is produced in the plant and its potential to be toxic to humans and other organisms.

Before pesticides can be marketed, the EPA considers factors regarding PIPs such as: 
- Risks to humans 
- Risks to non-target organisms and the environment 
- Gene flow potential 
- Insect resistance management plans 
The EPA also requires certain tests to be conducted to identify any risks to humans and the environment. These tests are listed below. 
- Identification of new genetic material and all new proteins 
- Mammalian toxicity testing of all new proteins 
- Comparison of new proteins to known toxins and allergens 
- Toxicity testing on birds, fish, earthworms, insects such as bees, ladybird beetles, and lacewings 
- Toxicity testing on insects related to target insect pests 

Length of time required for the new proteins to degrade in the environment
The development of a transgenic plant requires researchers to meet with one or more regulatory agency (EPA, USDA/APHIS, or FDA) to discuss the outline of the projects and decide which studies will be necessary to ensure safety of the end product. Throughout the study the developer sends the data of the ongoing research to the appropriate agency. For many biotech crops, the product then goes through a deregulation process in which the USDA/APHIS reviews the data received from the developer and decides whether or not the transgenic plant causes a negative outcome in the environment by genetically crossing with native species or out-competing them. They also try to ensure that the transgenic plant does not have any negative effects on wildlife, and does not become a “super-weed.” The overall goal of the regulatory agencies is to ensure that biotech crops are as safe as their non-genetically modified counterparts.

Successfully Preventing a “Super-weed” and Insect Resistance?

A “super-weed” can occur in two ways: (1) when pollen from a genetically modified crop pollinates a weedy relative and that weedy relative then becomes resistant to the herbicide that was originally produced to kill it, and (2) when an herbicide-tolerant crop escapes cultivation and becomes a weed. For this reason, the EPA developed a regulatory framework to help ensure that the appropriate tests are done to maintain that biotech crops are safe for the environment.

The infestation of superweeds has more than doubled since 2009, according to Dow Chemical, which also states that an estimated 70 million acres of U.S. farmland are infested with pesticide-tolerant weeds that cost roughly $1 billion in damages to crops so far.

In an email response to, a Dow spokesperson wrote: "We agree with our critics that with unvarying use of the same model of weed control action ... weeds will adapt. We differ from critics however, in that we believe the best way to promote responsible use of weed control technology is to provide growers with the broadest practicable range of weed control options."

Weed resistance to Roundup has forced farmers to turn to higher-risk herbicides such as 2,4-D, one of the components of Agent Orange used in the Vietnam War. As a supposed solution to the Roundup-resistance, biotech companies have genetically engineered corn and soybeans to be tolerant of 2,4-D. As the biotech companies try to get these new crops approved, scientists and organizations worry what effect that will have on the environmental, air, and water. The study from Environmental Sciences Europe projects that if these new crops are approved, the volume of 2,4-D sprayed could increase herbicide usage by about another 50%.

Other companies making grains resistant to herbicides include Pioneer, Syngenta and Monsanto, the world's largest producer of GMOs.

A concern with insect resistant crops, such as Bt corn, is that insects feeding upon the corn will eventually become resistant to the transgenic plant, defeating the purpose of growing the insect-resistant plant. The EPA has taken precautions to help prevent this scenario by suggesting that farmers who grow genetically engineered crops to also grow conventional crops nearby as “refuges” where insects aren’t exposed to the genetically modified crop that contain insect resistance. In theory this allows non-resistant insects to continue breeding and remain present in the environment, and mate with any resistant survivor of the genetically modified crop. A non-resistant insect that mates with a resistant insect helps to ensure that the dominant gene of non-resistance evolves from one generation to the next, which maintains a population of insects that will still be susceptible to the insect-resistant crops.

However, in the last several years, farmers and scientists have found rootworms with resistance to Bt corn. A study published in Proceedings of the National Academy of Sciences by entomologists at Iowa State University and the University of Illinois asserts numerous incidents in different states across the US of resistant rootworm.[8][9] Initially, the rootworm was only resistant to one of the three varieties of Bt corn. However, scientists have now found resistance to a second variety as well. In addition, developing resistance to one variety increases the chance of developing resistance to a second. So the effort of biotech companies to create new genetically engineered seeds with “stacked traits” in one doesn’t seem like a solution that will be effective in the long run.

To help combat the problem, scientists say larger refuges with non-Bt corn need to be planted as well as planting different crops year to year. While an advisory panel to the EPA back in 2002 said that 50 percent of each corn field should have only non-Bt corn, the biotech companies and EPA managed to merely recommend that 5 to 20 percent be dedicated to non-Bt corn.


Governmental regulatory bodies and practices in the US may not be as effective as we think (or hope). Contrary to the claim made by the biotech companies producing and patenting the genetically modified seeds, our herbicide and pesticide use has actually increased since the adoption of GMO crops. A study published by Environmental Sciences Europe found that between the years 1996 and 2011, herbicide use in the United States increased by 527 million pounds. Pesticide use is estimated to have increased by 404 million pounds, about 7%.  Additionally, the true toxicity of herbicides such as glyphosate, dicamba and 2,4-D is only now coming to light.

Similarly, the EPA has only made recommendations regarding the planting ration of Bt and non-Bt corn, and just as environmental scientists have predicted, we now have increasingly rampant infestations of Bt resistant rootworms.

Once again, this is the information I have been able to collect, but it would be best if you would do your own research and come to your own conclusions.