US-Umweltbehörde: Neue Policy für Nanotechnologien in Pestiziden

Background on Nanotechnology in Pesticides

FIFRA and EPA’s implementing regulations provide an effective framework for regulating pesticide products that contain a nanoscale material. Currently, the Office of Pesticide Programs (OPP) describes a nanoscale material as an active or inert ingredient of a pesticide and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

The special properties that make nanoscale materials of potentially great benefit also can present new challenges for risk assessment and decision-making. For instance, their small size may allow them to pass through cell membranes or the blood-brain barrier,
possibly resulting in unintended effects.

New Policy for Nanotechnology in Pesticides

Given the potential for nanoscale materials to pose different risks than their larger-sized counterparts, the EPA intends to obtain information on what nanoscale materials are present in pesticide products. We are making available a notice announcing our proposed plan for gathering information on nanoscale materials contained in pesticide products. This document, which will be published in the Federal Register soon, describes several possible approaches for obtaining certain additional information on the composition of pesticide products.

The notice includes three components, two that describe alternative approaches for gathering information on nanoscale materials in pesticide product and one that addresses issues related to new active ingredients:

• Use section 6(a)(2) of FIFRA to obtain existing information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment.
• Obtain information on nanoscale materials in pesticide products using data call-in notices under FIFRA section 3(c)(2)(B).
• The notice also proposes a new approach for how we will determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered.

Using the 6(a)(2) approach, EPA would rely on the requirement under FIFRA for a registrant to inform the agency of relevant information relating to their products. Specifically, at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant must provide such information to the Agency. If we adopt this approach, existing regulations would also require the inclusion of such information with any application for registration of a pesticide product that contains a nanoscale material.

Using data call-in notices under FIFRA section 3(c)(2)(B), we may send a DCI to a registrant requiring the registrant to provide additional data or other information, which the registrant may need to generate or compile. If we adopt this approach, we would also need to require the inclusion of this information with any application for registration of a pesticide product that contains a nanoscale material. We are reviewing whether this could be done under existing regulations or whether we would need to amend existing regulations to clarify that the information is required with any application for registration.
Next Steps

Once published, comments on the Federal Register Notice will be accepted until 30 days after publication in the Federal Register. The FR Notice of this action will be available at Regs.gov in docket number EPA–HQ–OPP–2010-0197.

After considering any public comments, we plan to issue a subsequent Notice in the Federal Register announcing our approach to gather this information and make ingredient determinations.

To read this notice of proposed policies, please see Nanotechnology prepublication notice.

How to Register a Product That May Contain Nanomaterials

Among its many potential applications, nanotechnology can be used to develop products that control pests, such as microorganisms on surfaces. EPA regulates products intended to control pests under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA has in place a rigorous evaluation and registration (i.e., licensing) program for all pesticides that are distributed or sold in the United States.

Producers of pesticide products must submit scientific and technical data for EPA review to ensure that the use of a pesticide will not generally cause unreasonable adverse effects on human health or the environment.

EPA strongly recommends that companies contact EPA’s pesticide registration Ombudsmen to arrange a pre-application conference as early as possible in the development of any pesticide that would be a product of nanotechnology or that would contain nanoscale material. During pre-application conferences, a company should provide EPA with information on:

•   how the pesticide is made,
•   how it is proposed to be used, and
•   how people and the environment may be exposed to the product.

EPA addresses these basic questions in the evaluation of any pesticide – regardless of the materials and methods by which it is made. However, because nanoscale materials may have special properties, EPA’s data requirements may need to be tailored to the specific characteristics of the product under consideration.

Pesticidal Applications of Nanotechnology

The use of nanoscale materials in pesticide products and treated articles may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of spray-applied surface disinfection. These could contribute to improved human and environmental safety and could lower pest control costs. For example, as a materials preservative, nanosilver should maintain its ability to reduce the number of odor causing bacteria longer and require smaller quantities than other silver preservatives due to an expected gradual and controlled release of silver ions from nanosilver as opposed to the rapid release of for example, silver ions from a zeolite structure or the immediate dissolution of a silver salt.

A number of organizations have considered whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. Government, academic, and private sector scientists in multiple countries are performing research into the human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. Recently, governmental and expert peer review organizations have reviewed and summarized this evidence and offered views about the implications of this evidence for environmental and human health and safety.

For more information on EPA nanotechnology efforts and federal government nanotechnology research:

Office of Science and Technology Policy June 9 Announcement

Pesticide Registration: Clarification for Ion Generating Equipment

National Nanotechnology Initiative

EPA White Paper on Nanotechnology, (136 p., 4 MB)

EPA Nanotechnology Research

Draft EPA Nanotechnology Research Strategy, (76 p., 1 MB)

Nanotechnology under the Toxic Substances Control Act

EPA Nanoscale Materials Stewardship Program

Quelle: US-Umweltbehörde (EPA) (in Englisch)