Biomedical Engineering Reference
In-Depth Information
Limiting the uses of the nanoscale materials
Requiring the use of personal protective equipment, such as impervious gloves and NIOSH
approved respirators
Limiting environmental releases
Requiring testing to generate health and environmental effects data
The EPA has permitted limited manufacture of new chemical nanoscale materials through the
use of administrative orders or SNURS. Under TSCA Section 5(a)(2), the EPA determines that a
use of a chemical substance is a significant new use after considering all relevant factors, including:
The projected volume of manufacturing and processing of a chemical substance
The extent to which a use changes the type or form of exposure of human beings or the
environment to a chemical substance
The extent to which a use increases the magnitude and duration of exposure of human
beings or the environment to a chemical substance
The reasonably anticipated manner and methods of manufacturing, processing, distribu-
tion in commerce, and disposal of a chemical substance
The EPA has also allowed the manufacture of nanoscale chemical substances under the terms of
certain regulatory exemptions, but only in circumstances where exposures are tightly controlled to
protect against unreasonable risks (e.g., the protective equipment and environmental release limita-
tions discussed above). *
The EPA has used its Significant New Use Rule (SNUR) authority to ensure that nanoscale mate-
rials receive appropriate regulatory review. The SNUR requires persons who intend to manufacture,
import, or process new nanoscale materials that are identical to chemical substances listed on the
TSCA Inventory, but in a way that diverges from the SNUR provisions, to submit a Significant New
Use Notice (SNUN) at least 90 days before commencing that activity.
The EPA reportedly is also developing a proposed rule under TSCA to require the submission of
additional information, something the FDA has yet to undertake. This rule reportedly would propose
that persons who manufacture defined nanoscale materials notify the EPA of certain information,
including production volume, methods of manufacture and processing, exposure and release informa-
tion, and available health and safety data. Such information would assist the agency in evaluating the
intended uses of the nanoscale materials and take action to prohibit or limit activities that may present
an unreasonable risk to human health or the environment. To obtain more of the information needed for
nanoscale materials, the agency may also seek to regulate a rule to require testing for certain nanoscale
materials that are already in commerce. The EPA has said it is particularly interested in classes of
nanoscale materials not already being tested by other United States and international organizations.
The second statute EPA administers is the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). According to the EPA, FIFRA and implementing regulations provide an effective
framework for regulating pesticide products that contain a nanoscale material, a product of concern
from an environmental standpoint. The EPA has indicated that the special properties that make
nanoscale materials of potentially great benefit also can present new challenges for risk assess-
ment and decision-making. Given the potential for nanoscale materials to pose different risks than
their larger-sized counterparts, the EPA issued a notice in the Federal Register on June 10, 2011,
outlining what it was considering to address the situation. This document describes several possible
approaches for obtaining certain additional information on the composition of pesticide products.
* Id.
See fn.8.
U.S. Environmental Protection Agency. 2011. Regulating pesticides that use nanotechnology. http://www.epa.gov/pesti-
cides/regulating/nanotechnology.html.
Search WWH ::




Custom Search