EPA Statement on Glyphosate

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EPA is currently reassessing glyphosate as part of its scheduled registration review (the periodic reevaluation required by FIFRA every 15 years) and coordinating its re-evaluation with Canada's Pest Management Regulatory Agency. EPA’s 2012 human health risk assessment of glyphosate (2012) concluded that when used according to the EPA-approved label directions, the pesticide meets the statutory safety standards. During registration review, the EPA will update the existing human health and ecological risk assessments based on the best available scientific data. We will determine whether any risk mitigation is needed to ensure that glyphosate can continue to be used without unreasonable risks to people or the environment, including species like the monarch butterfly. We expect to release for public comment the preliminary ecological and human health risk assessments for glyphosate later in 2015. If at any time EPA discovers that the use of a registered pesticide may result in unreasonable adverse effects on people or the environment, we will take action to remove it from the marketplace or limit its use.
 
For the latest glyphosate tolerances please go to following link for the CFR:
 
 
 
What sort of tests are done when evaluating the safety of a pesticide like glyphosate?
 
We encourage anyone interested in the pesticide registration process to visit: http://www2.epa.gov/pesticide-registration/about-pesticide-registration.
 
The data needed to register a new active ingredient or product depends on the use pattern and the type of pesticide.  For a new active ingredient, the Agency may require up to 150 studies.  For a full explanation of the required studies, please see:

http://www2.epa.gov/pesticide-registration/data-requirements
 
EPA may require the following depending on use pattern:
 
Product Performance tests
 
Domestic animal safety studies
Studies that determine hazard to humans – the general public, infants and children, and workers – including acute, subchronic and chronic studies.  We also require studies to assess the potential for special sensitivity in infants and children.
 
If the pesticide is to be used on food or feed, residue chemistry studies are required to determine both the residues of concern and the amount of those residues likely to remain in human food and livestock feedstuff, including metabolism studies, field trials, livestock feeding studies, and rotational crop studies.
 
If the pesticide is to be used on food or feed, EPA evaluates residue monitoring data from the U.S. Department of Agriculture’s Pesticide Data Program and from the Food and Drug Administration’s monitoring program.
 
EPA determines potential residues in drinking water using agency-developed, peer reviewed models and monitoring data if available.
Studies that determine hazard to non-target organisms, including acute, subacute, chronic, and field studies. Studies include testing the pesticide active ingredient and any degradation products for toxicity to birds, mammals, terrestrial invertebrates, fish, aquatic invertebrates, estuarine and marine organisms, and aquatic and terrestrial plants. 

Laboratory and field studies to determine the stability and mobility of the pesticide and its degradation products in the environment as well as to understand its potential to bioaccumulate in organisms. Studies include: 1) pesticide degradation in water, sunlight, soils and sediments; and 2) pesticide volatility in the atmosphere, retention in soil, and migration potential to surface and ground waters.
Pesticide Spray Drift Evaluation
 
The agency has the authority to request additional information to address chemical-specific data gaps critical to the adequate assessment of human health and environmental exposure.
 
How does the EPA establish the acceptable daily intake of pesticides?
 
Where pesticides may be used on food or crops used to feed animals, the EPA sets tolerances, also known as maximum residue levels, for the amount of the pesticide that can legally remain in or on foods. It is important to note that the tolerance, or maximum legal residue, is not the same as an “acceptable daily intake.” When establishing the tolerance, the agency determines the maximum residue that can be expected based on the proposed use, and then makes sure it is a safe level after taking into consideration all other uses of that chemical, plus other potential sources of exposure.
 
For more information on pesticide tolerances, see www.epa.gov/pesticides/regulating/tolerances.htm. For information on how EPA sets these tolerances, go to www.epa.gov/pesticides/factsheets/stprf.htm.
 
How often do pesticides need to be re-evaluated?
 
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the primary federal law that governs the regulation of pesticides, requires EPA to reevaluate registered pesticides at least every 15 years. See http://www2.epa.gov/pesticide-reevaluation
 
What obligations do chemical manufacturers have on the review process?
 
In passing FIFRA, Congress placed the obligation on the pesticide manufacturer rather than EPA and taxpayers to develop and fund data development in support of pesticide licensing decisions. In order to gather sufficient information for its determinations, EPA requires more than 100 different scientific studies and tests from applicants.
 
But EPA does not rely on registrant generated studies alone. In addition those studies, EPA scientists review studies from peer-reviewed scientific journals and data from a wide variety of sources, including other governments and academia. In this way, they identify hazards and characterize risks to ensure that decisions are informed by the best science available (see:http://www.epa.gov/pesticides/science/literature-studies.html)
 
The agency uses these data to conduct risk assessments and determine whether a pesticide meets the statutory standard for registration – that is, whether the pesticide can be used without causing unreasonable adverse effects on human health and the environment and with a reasonable certainty of no harm from dietary and residential exposure.
 
EPA has strict standards and policies to help ensure that the data it relies on, whether registrant-developed or from another source, represent sound science. For example, EPA has an extensive set of guidelines and protocols that registrants use in developing required data. Once studies are submitted to the agency, EPA scientists conduct extensive analysis of the raw data to ensure that the design of the study is appropriate and that the data are collected and analyzed accurately. EPA scientists also carefully evaluate and consider peer reviewed studies from other sources in our regulatory decisions. When compelling data make it clear that regulatory action must be taken,  EPA responds appropriately.  See our Imprelis web pages: http://www.epa.gov/pesticides/regulating/imprelis.html  as an example. EPA takes regulatory action when the evidence is supported by  the preponderance of data.