It is springtime and farmers are applying millions of pounds of the world’s most common herbicide to the agricultural land in the United States. This year the U.S. Environmental Protection Agency (EPA), which licenses and regulates Roundup and the seven hundred fifty other products containing glyphosate (and the many adjuvants and surfactants added to it), must decide whether the herbicide is safe for prenatal, infant, child and adult consumption in food crops and products—and the agency is stalling.
The European Commission is also stalling, delaying a reauthorization of glyphosate under a peer review re-evaluation of the EU’s list of approved active substances. Currently, France, Italy, Sweden and the Netherlands are opposed to the relicensing of glyphosate, while Germany is abstaining.
In the U.S., the EPA is under a federal mandate requiring the agency to re-evaluate all pesticides on a fifteen-year cycle. The federal regulatory agencies (EPA, USDA, FDA) that establish food safety regulations claim the world’s most commonly used herbicide is as safe as table salt if used according to the directions.
CONFLICTING ASSESSMENTS
So why doesn’t the EPA just go ahead and reregister the license for glyphosate use in agriculture?
One reason is that in 2015 the World Health Organization’s International Agency for Research on Cancer (IARC) assessed glyphosate and its products as a probable human carcinogenic health risk, and this year the California state government intends to list the herbicide as a carcinogen.
The California Office of Environmental Health Assessment (OEHHA) intends to list glyphosate as a carcinogen under the mandates of state law Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986).1
So far, the EPA hasn’t agreed with the California OEHHA and World Health Organization’s IARC assessment of glyphosate and its products as a human carcinogenic health risk.
Clinical, peer-reviewed studies by science, industry and government bodies show that glyphosate kills plants and bacteria by interfering with an enzyme producing aromatic amino acids, which are essential for life in plants, bacteria and humans. The EPA and glyphosate manufacturers admit that consumers absorb glyphosate in minute amounts from food and drinking water, but assure us that it harms only plant life and passes harmlessly through the body in urination.
“All labeled uses of glyphosate are safe for human health and supported by one of the most extensive worldwide human health databases ever compiled on an agricultural product,” states Dr. Philip Miller, vice president global regulatory affairs for Monsanto, the manufacturer of Roundup.
Not so, says an international contingent of scientists. These scientists, using peer-reviewed clinical data, defend the IARC assessment that glyphosate poses a human health risk. They argue that the U.S. EPA and the European Food Safety Authority (EFSA) have cited biased industry-sponsored clinical data to argue that glyphosate is safe, and didn’t consider the low-dose effects in prenatal, infants and children.
“The science consisted solely of toxicologic studies commissioned by the herbicide manufacturers in the 1980s and 1990s and never published, not an uncommon practice in U.S. pesticide regulation,” say Philip J. Landrigan, MD, and Charles Benbrook, PhD in their New England Journal of Medicine report “GMOs, Herbicides, and Public Health.”2
“These studies predated current knowledge of low-dose, endocrine-mediated and epigenetic effects and were not designed to detect them. The risk assessment gave little consideration to potential health effects in infants and children, thus contravening federal pesticide law,” Landrigan and Benbrook say.
The exponential increase in the agricultural use of glyphosate over the past two decades and its correlation with human health issues involving neurological, intestinal and cancer disorders, is hotly contested by both sides of the glyphosate safety debate.
“I personally believe that glyphosate is the main reason why we have an epidemic in autism. I think it’s also responsible for the rise in non-Hodgkin’s lymphoma, pancreatic cancer, thyroid cancer, inflammatory bowel disease, ADHD, COPD, Alzheimer’s, diabetes, obesity and probably several other chronic conditions that we face today,” says Stephanie Seneff, a senior research scientist at the Massachusetts Institute of Technology (MIT).
“I don’t agree with the WHO’s designation as probably carcinogenic,” she says. “I think it is definitely carcinogenic.”
HIGH STAKES
The stakes are huge in this political-scientific schism. The future of the global, proprietary, agro-industrial, glyphosate-ready, genetically modified organism (GMO) crops lies in the resolution of the split between the World Health Organization’s IARC (claiming glyphosate causes cancer) and the U.S. EPA and EFSA (claiming glyphosate is safe).
Food manufacturers using GMO crops also have a huge stake in the outcome of this debate. Over 90 percent of U.S. corn, soy and sugar beet crops are grown with glyphosate, and these GMO crops and their products constitute over 80 percent of processed food items. Glyphosate is also used as a desiccant in the production of wheat and other grains.
Kellogg’s, a Fortune 500 food manufacturer, acknowledges that grains purchased on the open market containing herbicides including glyphosate are consumed by customers in their processed products. “Nearly all crops in the U.S. are treated with herbicides and pesticides, and may leave behind very low residue levels on some foods,” says a Kellogg Company customer service spokesman.
“In the U.S., the acceptable level of pesticide and herbicide use in crops is set by the Environmental Protection Agency (EPA) based on a standard of reasonable certainty that the use would cause no harm to human health or the environment,” says the company spokesman. However, U.S. federal agencies in charge of protecting the public’s health with a “standard of reasonable certainty”—namely EPA, USDA and FDA—state that they have never looked at glyphosate residues in federal aggregate food crop tests (outside of one USDA test on soy in 2011), while citing manufacturer and EPA laboratory tests claiming there is no human health risk. They also insist that glyphosate herbicides are safe if used under direction. These same federal agencies also authorized the safety of “Roundup Ready” transgenic GMO crops as “substantially equivalent to nature,” and give GMO glyphosate-ready crops a pass from federal food testing requirements.
Meanwhile, California OEHHA intends to list glyphosate as a carcinogen under the mandates of state law Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act of 1986). “The law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65. Labor Code section 6382(b)(1) refers to substances identified as human or animal carcinogens by IARC.”
AGGREGATE TESTING
It’s a complicated byzantine federal process claiming to prove that glyphosate isn’t a health risk but when unraveled, a secret emerges—the licensing of glyphosate and its products is in violation of the federal laws governing pesticides. The Federal Food Drug and Cosmetic Act (FFDCA) and the Food Quality Protection Act (FQPA) both mandate aggregate testing of food crops and products to account for the accumulated exposures of the herbicide’s chemical residue in commonly consumed foods. However, U.S. federal agencies (EPA, USDA, FDA) claim that no government aggregate food testing of glyphosate residues has occurred, so the EPA uses “available information.”
WHAT ARE AROMATIC AMINO ACIDS?
Aromatic amino acids (AAA) are amino acids that include an aromatic ring, such as six-carbon benzene (C6H6) or some other similar ring structure. Examples include the essential amino acids phenylalanine (which the body makes into norepinephrine and thyroxine), tryptophan (which the body makes into serotonin) and histidine.
Animals and humans get aromatic amino acids from their diet, but all plants and micro-organisms must synthesize their aromatic amino acids through the metabolically costly shikimate pathway in order to make proteins. Herbicides like Roundup and antibiotics work by inhibiting enzymes involved in aromatic
Phenylalanine
acid synthesis, thereby rendering them toxic to plants and micro-organisms but—according to claims by pesticide
manufacturers—not to animals.
These claims do not take into account the role of gut flora in human and animal health. Herbicides like Roundup are toxic to all microorganisms, including those that inhabit our intestines—with unknown but certainly harmful consequences.
Furthermore, the FDA touts the FQPA Safety Factor as an additional ten-fold safety factor to protect for special sensitivity to pesticide exposures in infants and children. This may include residues in food, drinking water or residential exposures; but the EPA admits to waiving the FQPA Safety Factor for glyphosate, reducing it from ten to one.
“If you are asking if glyphosate is safe, then yes, we have said that glyphosate does not cause unreasonable adverse effects to human health and the environment so long as it is used according to the pesticide labels,” says Khue Nguyen, Chemical Review Manager, Risk Management and Implementation Branch 1, Pesticide Re-evaluation Division, Office of Pesticide Programs of the EPA.
“EPA regulates pesticides, which means we deal primarily with pesticide policy and we determine what appears on the pesticide labels. We do not do food safety inspections or testing on food/feed commodities. To be clear, we set tolerances for all pesticides that are used on food/feed commodities. A pesticide having a tolerance or multiple tolerances does not mean that it is unsafe,” says Nguyen.
Section408(b)(2)(A)(i) of the Federal Food Drug and Cosmetics Act states that EPA can establish a tolerance for a pesticide chemical residue in or on food only if EPA determines that the tolerance is safe. “Safe” is then defined as a “reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures.”
Consumer advocates claim that without
the government providing a transparent aggregate testing of glyphosate chemical residue in food, there is no total accounting for the public’s cumulative exposure to the herbicide in a daily diet; hence, no safety mandate maximum residue levels (MRL) can be established.
“The legal process for tolerance setting must be based on human health effects from dietary exposures. However, without data on actual residues on these crops, this cannot be verified. We have challenged EPA’s tolerance setting before and will continue to do so,” says Nichelle Harriott, science and regulatory director, Beyond Pesticides.
THE IR-4 PROJECT
In a little publicized federal government program called the IR-4 Project, the USDA, EPA and glyphosate manufacturers do test glyphosate tolerance residue on crops, but without transparency to the public.
The United States Department of Agriculture-funded IR-4 Project, which partners with the EPA, state government agencies, glyphosate manufacturers, and universities, has been testing glyphosate residues in food crops and feed to facilitate the herbicide’s use in agriculture. IR-4 sounds like a federal secret, but when it petitioned the EPA in the Federal Register to increase food crop MRL residue tolerance levels of the world’s most popular herbicide, it gave away its cover.3
This IR-4 petition went unnoticed in the shadow of Monsanto’s (an IR-4 member) EPA petition to use Roundup on root and tuber vegetables, oilseeds, teff forage and hay; and certain vegetables and fruit, including citrus and berries.4 The petition was approved by the EPA (also an IR-4 member).
Headquartered in Princeton, NJ, the IR-4 operates as a “unique” partnership among the USDA, EPA, the National Institute of Food and Agriculture (NIFA), the Agricultural Research Service (ARS), the State Agricultural Experiment Stations (SAES), agrochemical industry, universities, commodity groups and growers.5 Monsanto, Syngenta, DuPont, Dow, Bayer, and BASF are listed in the IR-4 directory.6
With a staff of over one hundred twenty-five full-time members, the IR-4 Project pursues its mission to “facilitate registration of sustainable pest management technology for specialty crops and minor uses.” Specialty crops tested by IR-4 include commonly consumed food crops (such as fruits, vegetables, nuts, herbs and spices) and non-food plants and flowers used in landscaping.
“As some background, for more than fifty years the USDA-funded IR-4 Project is the only resource for facilitating registrations of conventional chemical pesticides, biopesticides and organic products for growers of specialty crops and other minor uses (specialty uses) in the United States. These are uses not supported by registrants. IR-4 is a partnership with government, industry and growers,” says Jerry J. Baron, Ph.D, executive director of the IR-4 Project.
“We typically develop residue exposure data to assist EPA with their risk assessment. Basically we apply the test product the way the farmer would potentially use the pesticide or biopesticide. When the crop is mature, we harvest the raw agriculture commodity and analyze for the presences of the chemical, biochemical and/or metabolites,” says Baron.
What was the IR-4’s urgent need to increase exponentially the herbicide residue levels allowed on such foods as carrots, sweet potatoes, fruits, grains and berries?
“The IR-4 Project received multiple requests for assistance to facilitate modifications to the registration of glyphosate from public sector scientists with USDA and the State Agricultural Experiment Stations. These requests were reviewed during IR-4 Project Food Use Workshops and classified as high priority,” says Baron.
The IR-4 insists there is no conflict of interest with government regulatory bodies and glyphosate industry manufacturers collectively using their testing data to petition the EPA in the Federal Register to increase glyphosate MRL levels for crops.
“Though IR-4’s data development is independent of the companies, IR-4 submissions are coordinated with the companies. Due to provisions of the Pesticide Registration Improvement Act, IR-4 submissions are often classified as part of a company submission,” says the IR-4 executive director. The IR-4 also insists their hidden glyphosate residue data developed under USDA and EPA testing standards are “different” from the USDA MRL monitoring data used in national USDA food surveys to protect the health of the public.
“The data IR-4 develops are much different than glyphosate monitoring data by EPA and USDA; we are fully removed from that activity. USDA just released a report within the last couple of weeks from their Pesticide Data Program out of the Agriculture Marketing Service. You may find some glyphosate monitoring data in that sample set,” says Baron.
THE PESTICIDE DATA PROGRAM
The USDA Pesticide Data Program (PDP) Annual Summary report is conducted by the USDA Agricultural Marketing Service (AMS) to collect data on pesticide and herbicide residues in over ten thousand samples of fruit, vegetables, fresh and processed products, and infant formulas throughout the U.S. using the MRL tolerances set by the EPA. These PDP data are presented to the public to assure consumers the food they feed their families is safe.
“Ultimately, if the EPA determines a pesticide is not safe for our families it is removed from the market,” states the USDA in their 2014 PDP report—but the USDA admit they don’t test in the PDP for the most commonly used herbicide in the U.S. (glyphosate) in food crops and food products—except for one USDA soy test in 2011.
“The PDP tests a wide variety of domestic and imported foods using a sound statistical program and the most current laboratory methods. Glyphosate is not detectable using the multi-residue methods (MRM) the PDP testing laboratories use and would require a specialized method. Glyphosate requires the single analyte method to test for residues,” says Peter Wood, spokesman for the public affairs office of the USDA AMS. When asked why the USDA PDP didn’t use USDA-funded IR-4 glyphosate residue MRL data for those foods listed in the annual survey, the USDA spokesman said, “the report does not include data from other sources.”
Why then doesn’t the USDA employ the single analyte method used in the 2011 PDP testing of three hundred soybean samples for glyphosate and its metabolite AMPA (aminomethylphosphonic acid)?
“USDA and EPA specialists discuss the selection of commodities and pesticides for testing. With USDA’s scientific input and EPA’s data needs, EPA makes the determination which commodities and pesticides are tested,” says Wood. “Currently, the U.S. Food and Drug Administration (FDA) is testing corn and soybean grains for glyphosate residues. EPA is waiting on the results from FDA testing before making the determination if additional data are needed for its ongoing evaluation of glyphosate tolerances to ensure that the levels set by EPA meet the safety standards prescribed by the law,” he says.7
The FDA is responsible for enforcing EPA pesticide tolerances, but admits this is the first time they have ever tested for glyphosate MRLs in any food commodity. “FDA has not routinely looked for glyphosate in its pesticide monitoring regulatory program for several reasons, including that available methods for detecting glyphosate were selective residue methods that would have been very expensive and labor-intensive to implement in FDA field labs,” says Charlotte Lian, Ph.D., Plant Products Branch, Division of Plant Products and Beverages, Office of Food Safety Center for Food Safety and Applied Nutrition, Food and Drug Administration.8
“FDA is aware of the 2015 IARC World Health Organization’s assessment of glyphosate. In the U.S., risk assessments of pesticides are conducted by EPA,” says Lian.
CIRCULAR NON-ANSWER
How were glyphosate and the seven hundred fifty products containing it licensed without abiding by the aggregate tolerance residue testing data mandates for risk assessments under the Food Quality Protection Act? The EPA dodges the question. Anne Overstreet, Chief Communication Services Branch, Field and External Affairs Division Office of Pesticide Programs, Environmental Protection Agency says, “The Federal Food, Drug, and Cosmetic Act states: To make the safety finding, EPA considers, among other things: the toxicity of the pesticide and its break-down products, aggregate exposure to the pesticide in foods and from other sources of exposure, and any special risks posed to infants and children.”
“While testing for aggregate exposure is nearly impossible—people eat different foods, combinations of foods, and amounts of foods—EPA uses models to assess likely aggregate exposure and adds an additional safety factor to further protect consumers, especially children, as required by the Food Quality Protection Act.”
“In setting tolerances, EPA must make a finding that the tolerance is ‘safe,’ with safe being defined as meaning that there is a ‘reasonable certainty that no harm will result from aggregate exposure to the pesticide residue.’”
Overstreet then refers to the USDA PDP aggregate exposure testing as proof consumers shouldn’t worry about pesticides residues on their food—even though the 2014 PDP didn’t test for glyphosate. “The PDP data demonstrate that overall pesticide residues found on foods tested are at levels below the tolerances established by EPA and pose no safety concern. Based on the PDP data, consumers can feel confident about eating a diet that is rich in fresh fruits and vegetables,” says Overstreet. But what about a diet rich in grains and soy-fed eggs, milk and meat?
“Glyphosate residue data are not part of 2014 PDP sampled pesticides. To find out whether FDA has plans to test for glyphosate residues, please contact FDA directly,” she says.
This type of circular non-answer on glyphosate’s safety is how the EPA has been stalling their decision to reregister the herbicide and its products, thus permitting its continued use. The EPA also hasn’t responded on whether the herbicide’s current MRL tolerance residue levels are in violation of the FQPA Safety Factor protecting prenatal, infants and children.
“The real question is whether the EPA was in violation of the law when glyphosate was approved then and now,” says Jonathan Evans, Environmental Health legal director and senior attorney for the Center for Biological Diversity.
CONCLUSION
Based on the mandates of the Food, Drug and Cosmetic Act as well as the Food Quality Protection Act, glyphosate should be illegal.
Specifically those acts call for aggregate testing of food products to determine the chronic and acute risks of a pesticide on your body. Once aggregate testing has been carried out, the FDA will mandate MRLs for that product. Then the product will carry instructions for the farmer or homeowner on how much to apply—often given in an amount per acre.
All of this requires aggregate product testing, which the agency openly admits they have not conducted (with the exception of glyphosate for soy in 2011). This is a bureaucratic process—modeling acute and chronic estimates and applying the results to a billion-dollar industry.
In fact, the division of EPA that actually enforces pesticide tolerance levels has never enforced this regulation—there has never been a recall because a pesticide is over limit.
In 2013, the IR-4 increased the tolerance level of glyphosate for many crops across the board—“helping industry” get this valuable tool applied to other crops. For fifty years, the IR-4 project has helped the pesticide industry get licences. They do testing but do not reveal the results. IR-4 generally allows the highest amount requested with no science to back up their decisions.
Meanwhile, the consumer is the victim of this bureaucratic farce.
REFERENCES
1. http://oehha.ca.gov/prop65/CRNR_notices/admin_listing/intent_to_list/090415LCset27.html.
2. Landrigan PJ1, Benbrook C. GMOs, Herbicides, and Public Health. N Engl J Med. 2015 Aug 20;373(8):693-5.
3 . https://www.regulations.gov/index.jsp#!documentDetail;D=EPA-HQ-OPP-2012-0132-0009.
4. http://www.regulations.gov/#%21docketDetail;D=EPAHQ-OPP-2012-0132; https://www.gpo.gov/fdsys/pkg/FR-2013-05-01/pdf/2013-10316.pdf; http://www.regulations.gov/#!documentDetail;D=EPA-HQOPP-2012-0132-0009.
5. http://nifa.usda.gov/topics; http://ir4.rutgers.edu/directory.cfm?nd=nd&letter=B.
6. http://ir4.rutgers.edu/directory.cfm?nd=nd&letter=B.
7. http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184293.htm.
8. http://www.fda.gov/downloads/Food/ComplianceEnforcement/ucm073186.pdf.
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