“Policy makers and regulators are regularly called on to make decisions based on the best information/science available at the time, which is often incomplete. That’s where considerations such as risk tolerance and level of protectiveness come into the discussion, and these factors are more about societal values than scientific knowledge.” — Sharon Lotthammer, Minnesota Pollution Control Agency
At the first Sustainable We forum, “Parks, Pollinators and Pesticides,” 40 engaged Minneapolis residents talked about how our toxic chemicals are regulated, who makes risk assessments, where the scientific data comes from, and whether we trust governmental agencies with our safety.
This is a lengthy overview of the process of how pesticides are regulated.
U.S. Standards Compared to Europe
Sustainable We forum panelist Dr. Vera Krischik, University of Minnesota expert in integrated pest management, indicated that Europe tends to set standards differently than the U.S. In Europe, money is provided for research laboratories to test products on behalf of agencies, rather than relying on product manufacturers to offer scientific data. They take a precautionary approach — if data indicates potential impact on health, the product is restricted. In the U.S., on the other hand, data must show actual impact before it is restricted. European labs tend to have the resources to review product data more frequently than in the U.S.
A Specific Look at Roundup
Glyphosate, the active ingredient in Monsanto herbicide Roundup, is widely used to control grass and weeds, and impacts food crops. It was classified by the International Agency for Research on Cancer (IARC), an arm of the World Health Organization (WHO), as “probably carcinogenic to humans.”
According to an April 2015 article in The Guardian (U.K.):
- Several European countries, including Holland, Denmark and Sweden, have banned or restricted the use of glyphosate herbicides, because of alleged links with a variety of health problems – not just cancer – ranging from birth defects and kidney failure to celiac disease, colitis and autism.
- Another study, in Argentina, suggests a correlation between glyphosate use and the decline in activity in honeybee colonies.
- In New York, an environmental group is suing the Environmental Protection Agency for ignoring the dangers of glyphosate which, it claims, has resulted in the demise of the monarch butterfly population.
- Glyphosate has been linked to tumors in mice and rats – and there is “mechanistic evidence,” according to the IARC, of DNA damage to human cells from exposure to glyphosate.
- Cities, including Chicago and Paris, are making their public spaces glyphosate-free. The City of Vancouver bans the public and private use of herbicides, including glyphosate, aside from the treatment of invasive weeds like Japanese knotweed.
How Are Toxic Products Regulated?
Prior to the forum, representatives at the Minnesota Department of Agriculture (MDA) — which regulates these issues in our state — offered me insights on how the process works. MDA indicated that their responses refer to pesticides, “which include herbicides, insecticides, fungicides, rodenticides, algaecides, and repellents.”
They indicated state regulation is derived from U.S. Environmental Protection Agency (EPA) direction, which sets standards nationwide per two major statutes and two amendments.
- Registration of products is based on evaluation of scientific data and risk/benefit assessments. Label directions are offered to help control product use (Federal Insecticide, Fungicide and Rodenticide Act).
- Tolerances are determined for pesticides used for food or animal feed, with strong provisions to protect children (Federal Food, Drug and Cosmetic Act).
- The Food Quality Protection Act of 1996 must find that a pesticide poses a “reasonable certainty of no harm before it can be registered for use on food or feed. The EPA must review each pesticide registration at least once every 15 years.
To be registered for use, the product manufacturer “must provide data from studies that comply with EPA’s testing guidelines.” Risk assessments evaluate the potential for:
- Harm to humans, wildlife, fish, and plants, including endangered species and non-target organisms.
- Contamination of surface water or ground water from leaching, runoff, and spray drift.
It is up to customers to use the product properly, according to label instructions. States are charged with monitoring and enforcing against illegal pesticide use. In Minnesota, that task falls to the MDA.
About Scientific Data[pullquote align=”full” cite=”” link=”” color=”” class=”” size=””]I asked MDA, “Aren’t these decisions sometimes limited by data that comes from companies that sell the product (an alternative being taxpayers?), and how trustworthy is that? How does the EPA, for example, qualify good laboratory practices and verify the trustworthiness of studies before rendering a verdict on a product?”[/pullquote]
Their lengthy response excerpted EPA website information about:
- Assessing risk
- Data required for regulation
- Laboratory testing guidelines
- Results of laboratory inspections
According to the MDA, the EPA’s human health risk assessments address questions such as:
- What types of health problems are caused by pesticides in the environment?
- What is the chance that people will experience problems when exposed to different levels of pesticides?
- Is there a low level below which some chemicals don’t pose a human health risk?
- What pesticides are people exposed to and for how long?
- Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnic practices, gender, where they work, where they play, what they eat, etc.
In carrying out risk assessments EPA uses a four-step process that involves:
- hazard identification (whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances),
- dose response assessment (the numerical relationship between exposure and effects),
- exposure assessment (examines what is known about the frequency, timing, and levels of contact with a substance),
- risk characterization (examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides).
“The risk assessment process depends on having appropriate data and using well tested models and guidelines… Before allowing a pesticide product to be sold on the market, EPA ensures that the pesticide will not pose any unreasonable risks to plants, wildlife and the environment.”
Do We Trust Our Safety?
[pullquote align=”full” cite=”” link=”” color=”” class=”” size=””] I asked the MDA why Minnesota doesn’t restrict glyphosate products, as California, for example, does. [/pullquote]
They clarified that California’s Environmental Protection Agency follows Proposition 65, which requires a published state list of chemicals known to cause cancer, birth defects or other reproductive harm. That list now includes glyphosate. What this means is simply that California businesses are required to provide a ‘clear and reasonable’ health warning on Roundup and other glyphosate products. However, this listing does not restrict sales of the product.
On pesticides, the MDA told me, the IARC concerns raised about glyphosate “suggests that cancer could happen under some circumstances, [but] it does not indicate how likely cancer will happen under actual product use conditions or possible subsequent environmental exposures. The likelihood of developing cancer depends upon exposure levels and circumstances that might be relevant for humans, and these are things that IARC does not consider.”
MDA used the analogy that “sunlight can cause cancer (hazard), but in order to understand the likelihood of cancer occurring (risk), we need to know the amount or duration of exposure and the circumstances under which cancer is most likely to occur. IARC may identify that sunlight is a carcinogen, but does not advise as to how much sun exposure is ‘safe’ or what measures one can take to protect oneself while still enjoying a sunny day. In other words, IARC identifies cancer hazards, but does not define cancer risks.”
The MDA went on to say, “According to the EPA and Minnesota Department of Health, there is no information at this time to suggest that cancer could occur from the less frequent, lower-level exposures that may occur from occasional residential uses, or from occupational use of glyphosate while following appropriate safety and precautionary measures as provided on the label.”
In sum — with more on this to come in subsequent articles — the level of trust we place in governmental agencies about product safety generally depends on individual choices.
- How much do we trust the corporate data that the EPA tends to rely on?
- How much do we trust that the EPA has enough resources to oversee judgment on products coming to market and on inspecting testing labs and standards?
The EPA was rebuked in September 2015 by a federal court for approving the neonicotinoid insecticide “sulfoxaflor.” The Court concluded that federal law was violated when the EPA approved sulfoxaflor without reliable studies regarding its impact on honeybee colonies. The Court’s ruling means that the ingredient may not be used in the U.S. unless, and until, the EPA obtains stronger data about its impact on honeybees.[pullquote align=”full” cite=”” link=”” color=”” class=”” size=””]This year, the proposed fiscal 2016 spending bill in the U.S. Congress would cut EPA’s budget by $718 million, or 9 percent, compared with fiscal 2015.[/pullquote]
- More on the debate over glysophate, used in Roundup (The Guardian, U.K.)