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Rulemaking Underway Related to Disclosure of All Pesticide Ingredients

Inert Resources
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Contacts

Inert Ingredient Assessment Branch
PV Shah, Branch Chief
shah.pv@epa.gov
(703)308-1846


EPA is seeking comment on options for increasing public disclosure of all inert ingredients in pesticides registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA’s Advance Notice of Proposed Rulemaking (ANPRM) published in the Federal Register on December 23, 2009, and is available in the Public Docket (docket ID EPA-HQ-OPP-2009-0635). EPA received and granted two requests, from Responsible Industry for a Sound Environment and Sygenta Crop Protection, for a 90-day extension of the comment period from February 22, 2010, to April 23, 2010. For further information: http://edocket.access.gpo.gov/2010/pdf/2010-3415.pdf (1pp, 35 KB, About PDF).

This ANPRM is designed to initiate the regulatory process by informing the public about the issues surrounding the potential rulemaking and soliciting input that will help guide the Agency’s process to develop a proposal.

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Benefits to consumers of disclosure of inert ingredients

EPA believes disclosure of inert ingredients on product labels is important to consumers who want to be aware of all potentially toxic chemicals, both active and inert ingredients, in pesticide products.

What is an inert ingredient?

Pesticide products contain both "active" and "inert" ingredients. The terms "active ingredient" and "inert ingredient" are defined by the federal law that governs pesticides (Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA]). An active ingredient is one that prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant or nitrogen stabilizer. By law, the active ingredient must be identified by name on the pesticide product's label together with its percentage by weight.

All other ingredients in a pesticide product are called "inert ingredients." An inert ingredient means any substance (or group of similar substances) other than an active ingredient that is intentionally included in a pesticide product. Called “inerts” by the law, the name does not mean non-toxic.

Pesticide products often contain more than one inert ingredient. Inert ingredients play key roles in the effectiveness of pesticides. Examples include inerts that prevent caking or foaming, extend product shelf-life, or solvents that allow herbicides to penetrate plants.

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EPA's science review of inert ingredients

By federal law, products making pesticidal claims on their labels must only contain ingredients that have been approved by EPA. Both active and inert ingredients undergo science evaluation before approval.

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Disclosing inert ingredients increases transparency

EPA’s ANPRM outlines general options for inert disclosure on pesticide labels, including mandating disclosure only of potentially hazardous ingredients; mandating disclosure of most or all inert ingredient identities, regardless of hazard; and non-regulatory voluntary disclosure initiatives by pesticide registrants. The ANPRM solicits ideas for both regulatory and non-regulatory approaches and sets forth a series of questions for comment. EPA believes participation and comment by all stakeholders, including the public, is important for developing workable and effective solutions.

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EPA does not currently identify inert ingredients on pesticide labels

Pesticide manufacturers often claim as confidential the identities of inert ingredients in their products. Federal confidentiality regulations (40 CFR part 2, subpart B) require EPA to protect information claimed as confidential by companies. One exception is when EPA provides inert ingredient information to medical professionals treating persons in connection with exposure to a pesticide [FIFRA § 12(a)(2)(D) ].

EPA requires registrants to identify to the Agency all ingredients in their pesticide products. A challenge for inerts disclosure by registrants is that their pesticides may include proprietary products whose contents are held confidential by the manufacturer. EPA knows the composition of those proprietary products, but does not disclose it to registrants.

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Circumstances when EPA has required disclosure of inert ingredients

EPA now requires labels of pesticide products to identify any inert ingredient that it has determined is of "toxicological concern." In 1987, EPA required that the approximately 50 inerts of "toxicological concern" (called "List 1") must be listed on pesticide labels. Since then, nearly all List 1 ingredients have disappeared from pesticide formulations. Manufacturers replaced these toxic chemicals with less toxic ingredients.

Today, no List 1 ingredients are permitted in pesticides applied to food because they do not meet the stringent safety standards of the Federal Food, Drug, and Cosmetic Act. A very small number of List 1 chemicals can be used in pesticides applied to non-food sites if human and environmental exposures of concern are not expected, such as commercial plastics manufacturing. Also, certain states have their own regulations that require label identification of certain inert ingredients.

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Stakeholder involvement in inert disclosure

EPA has actively engaged the regulated community and other stakeholders on the topic of inerts disclosure. The Office of Pesticide Programs’ Pesticide Program Dialogue Committee (PPDC) considered disclosure options, information needs of the medical community, and other topics. PPDC’s discussions and final report continue to inform the Agency as EPA contemplates rulemaking to increase public availability of inert ingredients. The Agency will continue to involve stakeholders and the regulated community throughout any rulemaking process.

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Petitions to disclose inert ingredients

On September 30, EPA responded to two petitions (one by Northwest Coalition for Alternatives to Pesticides, and a second by certain State Attorneys General), that identified over 350 inert pesticide ingredients as hazardous. The petitioners asked EPA to require these inert ingredients be identified on the labels of products that include them in their formulations.

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