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Daily News Blog

14
May

Secrecy of Pesticide Safety Data and Ingredients Does Not Protect Public Health and the Environment

(Beyond Pesticides, May 14, 2018) Under EPA Administrator Pruitt’s proposed “transparency” plan, the public will still lack access to key data about the effects and efficacy of commercial poisons approved for sale and application in their communities and homes.

Tell EPA to adopt a real transparency plan for pesticides!

The proposed policy, posted on April 30 in the Federal Register, declares that it will “help ensure that EPA is pursuing its mission of public health and the environment in a manner that the public can trust and understand,” yet it applies only to a very limited set of studies used to support certain EPA regulations. The pesticide registration and review processes are particularly lacking in transparency, opportunity for public review, and access to data. Because pesticides are toxic chemicals broadcast into the environment, nowhere is transparency more important than in pesticide registration.

The proposed new policy does not cover pesticide registrations, warning labels, use restrictions, or proof of effectiveness. In the current process, the pesticide manufacturer produces the underlying data for these EPA approvals and controls access to them. Thus, despite Pruitt’s sweeping claims of “transparency in regulatory science”:

  • The public does not have access to the underlying data provided by the manufacturer to justify registering a new pesticide for commercial distribution;
  • Industry will not have to provide the data used to assess health and environmental effects and farmworker impacts to set allowable dietary and non-dietary exposure limits; and
  • On the product’s efficacy, the public also does not have access to the underlying data, nor does EPA even review manufacturer data on product effectiveness, except for very limited purposes.

To ensure full review, it is critical that the public and independent scientific community have complete access to safety testing data before poisonous pesticide products enter the marketplace. If EPA applies the proposed policy to pesticides, the failure to allow consideration of independent study results without disclosing confidential patient information will cripple the validity of EPA safety reviews. Furthermore, the failure to label all ingredients in pesticide products used by the public runs contrary to the basic principle of informed decision making.

Mr. Pruitt’s plan does not enable the public to have any meaningful information about “environmental health risk or safety risk,” as he claims. Under a false flag of scientific transparency, Mr. Pruitt’s scheme hobbles scientific work used to protect the public, but shields industry data that may demonstrate a public health peril.

EPA pesticide regulation is based on secret science.

Although EPA has proposed a rulemaking that purports to make science used in EPA regulatory decision making transparent and available to the public, the proposal applies only to “significant” EPA rulemakings, but not to matters such as pesticide registrations, through which private companies seek authorization to market products that may be harmful to public health and the environment. The pesticide registration and review processes are particularly lacking in transparency and opportunity for public review and access to data.

Data used to approve pesticides are not available to the public.
Pesticides are registered (authorized for use) based on studies and data submitted by the manufacturer (registrant) —not based on science conducted or commissioned by EPA. Such registrant data are not available for public review until after the pesticide is registered. The nonpublic data submitted by the registrant are used by EPA to assess health and environmental effects of the pesticide and impacts on farmworkers, and to set allowable human exposures through dietary and non-dietary routes —all without any opportunity for public review of the underlying data.

After registration, the public can access the materials on the basis of which the registration was granted only through making requests under the Freedom of Information Act (FOIA), a lengthy process. Even then, much information is withheld as purportedly “confidential.” If problems are identified that uncover a hazard from the pesticide, a member of the public would need to petition for a proceeding to cancel the registration, a long and unwieldy process during which the pesticide remains on the market.

EPA’s registration, registration review, and cancellation of pesticides raise numerous issues regarding the application of legitimate scientific process, risk assessment, exposure assumptions, sensitive populations, and the “reasonableness” of what are found to be “acceptable” hazards. Transparency of agency processes and underlying data is key to allowing public participation concerning these issues.

Full disclosure of known and unknown adverse effects is needed. 

EPA does not currently require that registrants disclose data submitted to EPA or label pesticides (including household pesticides) with data concerning the full extent of knowledge and/or ignorance of possible adverse effects, including data gaps and chronic health effects. Registrants’ exposure and toxicology studies are not released to the public so that any interested stakeholder can review them prior to a product being permitted on the market.

Conditional registration is missing crucial data.
Pesticide registrations under special circumstances, known as “conditional registrations,” allow widespread use of toxic chemicals that are not fully tested. Conditional registration of pesticides allows market entry for a product in the absence of certain data normally required for registration. As one glaring example, EPA came under scrutiny when it conditionally registered the neonicotinoid pesticide clothianidin, tied to dramatic declines in pollinators, without required pertinent field data on honeybees, even though the pesticide is known to pose risks to these vulnerable pollinators.

Efficacy data on pesticide products are lacking.
The public does not have access to, and EPA does not review, manufacturer data on pesticide efficacy, even though the statutory registration standard requires weighing the risks of pesticides against their benefits. Without efficacy information, the real benefits of a pesticide are unknown, and the reasonableness of pesticide use cannot be assessed. The lack of efficacy data review results in escalating and predictable insect and weed resistance, unnecessary increases in pesticide use, and increased risk for farmers of crop loss and economic damage. The only instance in which EPA evaluates pesticide efficacy is as a part of public health (not agricultural) pesticide registrations, and even this is without public disclosure or opportunity for comment.

Secret ingredients in pesticide products are not disclosed.
Currently, pesticide labels do not identify “inert” ingredients that have been classified as hazardous under a variety of environmental laws, including the Clean Air Act, the Clean Water Act, and the Emergency Planning and Community Right to Know Act. Disclosure would provide information about almost 400 hazardous chemicals in pesticide products.

Only active ingredients, not formulations, are tested.
EPA does not require testing data on the full formulation of a pesticide product, including all of the “inert” ingredients. Thus, data on the human health and environmental effects of the actual product on the market are entirely lacking.

The federal government needs a vision for pesticide policy across relevant agencies that seeks to replace outdated approaches and technologies, reliant on toxic chemicals, with green approaches advanced through incentives, assistance, and restrictions. This cannot be achieved without full transparency and disclosure of toxic hazards of pesticide products in the marketplace. Without full information on pesticide hazards, access to underlying data on hazards, and a transparent assessment of the reasonableness of risk (given the availability of less or non-toxic alternatives), the public is left in the dark. Credible reviews, subject to public oversight, are essential in EPA’s regulation of pesticides to prevent contamination of air, land, water, and food.

Tell EPA to adopt a real transparency plan for pesticides!

Letter to EPA Docket (Docket No. EPA-HQ-OA-2018-0259)

[Send to oei.docket@epa.gov]

Under the proposed “transparency” plan, the public will still lack access to key data about the effects and efficacy of commercial poisons approved for sale and application in their communities and homes. The proposed policy declares that it will “help ensure that EPA is pursuing its mission of public health and the environment in a manner that the public can trust and understand,” yet it applies only to a very limited set of studies used to support certain EPA regulations. The pesticide registration and review processes are particularly lacking in transparency, opportunity for public review, and access to data. Because pesticides are toxic chemicals broadcast into the environment, nowhere is transparency more important than pesticide registration.

The proposed new policy does not cover pesticide registrations, warning labels, use restrictions, or proof of effectiveness. Because the pesticide manufacturer produces the underlying data for these EPA approvals and controls access to them, no transparency will be provided in pesticide registration, in which:

* The public does not have access to the underlying data provided by the manufacturer to justify registering a new pesticide for commercial distribution;

* Industry will not have to provide the data used to assess health and environmental effects and farmworker impacts to set allowable dietary and non-dietary exposure limits; and

* Neither the public nor EPA has access to the underlying efficacy data, except for very limited purposes.

To ensure full review, it is critical that the public and independent scientific community have complete access to safety testing data before pesticide products enter the marketplace. If EPA applies the proposed policy to pesticides, the failure to allow consideration of independent study results without disclosing confidential patient information will cripple the validity of EPA safety reviews. Furthermore, the failure to label all ingredients in pesticide products used by the public runs contrary to the basic principle of informed decision making.

The proposal does not prevent EPA from issuing conditional registrations in the absence of required data, nor does it require industry to make that data publicly available at a later date.

It does not grant the public access to meaningful information about “environmental health risk or safety risk,” as claimed. Instead, the policy hobbles scientific work used to protect the public while shielding industry data that may demonstrate the public health peril.

EPA pesticide regulation is based on secret science.

Although the proposed rulemaking purports to make science used in EPA regulatory decision making transparent and available to the public, by its own terms it applies only to “significant” EPA rulemakings, where EPA is seeking to protect public health and the environment, but not to matters such as pesticide registrations, through which private companies seek authorization to market products that may be harmful to public health and the environment. The pesticide registration and review processes are particularly lacking in transparency and opportunity for public review and access to data.

Data used to approve pesticides are not available to the public.
Pesticides are registered (authorized for use) based on studies and data submitted by the manufacturer (registrant). Such registrant data are not available for public review until after the pesticide is registered. The nonpublic data submitted by the registrant are used by EPA to assess health and environmental effects of the pesticide and impacts on farmworkers, and to set allowable human exposures through dietary and non-dietary routes –all without any opportunity for public review of the underlying data.

After registration, the public can access the materials on the basis of which the registration was granted (which still may not include all underlying data) only through the Freedom of Information Act (FOIA), a lengthy process. Even then, much information is withheld as purportedly “confidential.” If problems are identified that uncover a hazard from the pesticide, a member of the public would need to petition for a proceeding to cancel the registration, a long and unwieldy process during which the pesticide remains on the market.

EPA’s registration, registration review, and cancellation of pesticides raise numerous issues regarding the application of legitimate scientific process, risk assessment, exposure assumptions, sensitive populations, and the “reasonableness” of what are found to be “acceptable” hazards. True transparency of agency processes and underlying data is key to allowing public participation concerning these issues.  

Full disclosure of known and unknown adverse effects is needed. 

EPA does not currently require that registrants disclose data submitted to EPA or label pesticides (including household pesticides) with data concerning the full extent of knowledge and/or ignorance of possible adverse effects, including data gaps and chronic health effects. Registrants’ exposure and toxicology studies are not released to the public so that any interested stakeholder can review them prior to a product being permitted on the market.

Conditional registration is missing crucial data.
Conditional registrations allow widespread use of toxic chemicals that are not fully tested. Conditional registration of pesticides allows market entry for a product in the absence of certain data normally required for registration. As one glaring example, EPA came under scrutiny when it conditionally registered the neonicotinoid pesticide chlothianidin, tied to dramatic declines in pollinators, without required pertinent field data on honeybees, even though the pesticide is known to pose risks to these vulnerable pollinators.

Efficacy data on pesticide products are lacking.
The public does not have access to, and EPA does not review, manufacturer data on pesticide efficacy, even though the statutory registration standard requires weighing the risks of pesticides against their benefits. Without efficacy information, the real benefits of a pesticide are unknown, and the reasonableness of pesticide use cannot be assessed. The lack of efficacy data review results in escalating and predictable insect and weed resistance, unnecessary increases in pesticide use, and increased risk for farmers of crop loss and economic damage. The only instance in which EPA evaluates pesticide efficacy is as a part of public health (not agricultural) pesticide registrations, and even this is without public disclosure or opportunity for comment.

“Secret ingredients” in pesticide products are not disclosed.
Currently, pesticide labels do not identify “inert” ingredients that have been classified as hazardous under a variety of environmental laws, including the Clean Air Act, the Clean Water Act, and the Emergency Planning and Community Right to Know Act. Disclosure would provide information about almost 400 hazardous chemicals in pesticide products.

Only active ingredients, not formulations, are tested.
EPA does not require testing data on the full formulation of a pesticide product, including all of the “inert” ingredients. Thus, data on the human health and environmental effects of the actual product on the market are entirely lacking.

The federal government needs a vision for pesticide policy across relevant agencies that seeks to replace outdated approaches and technologies, reliant on toxic chemicals, with green approaches advanced through incentives, assistance and restrictions. This cannot be achieved without full transparency and disclosure of toxic hazards of pesticide products in the marketplace. Without full information on pesticide hazards, access to underlying data on hazards, and a transparent assessment of the reasonableness of risk (given the availability of less or non-toxic alternatives), the public is left in the dark. Credible reviews, subject to public oversight, are essential in EPA’s regulation of pesticides to prevent contamination of air, land, water, and food.

Sincerely,

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    • Biological Control (13)
    • Biomonitoring (28)
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