Biomedical Engineering Reference
In-Depth Information
The notice focuses particularly on information about what nanoscale materials are present in reg-
istered pesticide products. Under one approach, the EPA would use Section 6(a)(2) of FIFRA to
obtain information regarding what nanoscale material is present in a registered pesticide product
and its potential effects on humans or the environment. If the EPA adopted this approach, 40 C.F.R.
152.50(f)(3) would also require the inclusion of such information with any application for registra-
tion of a pesticide product that contains a nanoscale material.
Under an alternative approach, the EPA would obtain such information using Data Call-In
notices (DCIs) under FIFRA Section 3(c)(2)(B). The EPA is reviewing whether this could be done
under existing regulations, or whether the EPA would need to amend existing regulations to clarify
that the information is required with any application for registration.
This document also proposes a new approach for how the EPA 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 (PRIA), even when an identical, nonna-
noscale form of the nanoscale ingredient is already registered. Using the Section 6(a)(2) approach,
the EPA would rely on FIFRA requirements for a registrant to inform EPA of relevant information
relating to their products. Specifically, if at any time after the initial registration of a pesticide the
registrant has additional factual information regarding unreasonable adverse effects on the environ-
ment of the pesticide, the registrant must provide such information to the agency. In the more recent
past, EPA seems to have abandoned its efforts to integrate FIFRA Section 6(a)(2) in this way.
The EPA is mirroring the FDA informal mechanism of strongly recommending that companies
contact the 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, the EPA would expect that
a company should provide 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.
*
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. That point is presently
being argued in a case in federal court. The case arose after the EPA announced on December 1,
2011, that it was conditionally registering a pesticide product containing nanosilver as a new active
ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a
preservative for a plethora of textiles. As a condition of FIFRA registration, EPA stated that it was
requiring additional data to confirm its assessment that HeiQ AGS-20 would not cause unreasonable
adverse effects on human health or the environment. The agency proposed granting the nanosilver
a four-year conditional registration.
On January 26, 2012, the Natural Resources Defense Council (NRDC) filed a lawsuit in the
U.S. Court of Appeals for the Ninth Circuit against the EPA concerning its conditional registration.
The NRDC sought to block the EPA from allowing nanosilver on the market without the legally
required data about its suspected harmful effects on humans and wildlife. In a brief dated April
16, 2012, the NRDC argued that the EPA's decision that HeiQ AGS-20 will not cause unreasonable
adverse effects on human health was not supported by substantial evidence. According to NRDC,
in calculating the risks to human health, the EPA failed to evaluate the risks to infants, even though
they have an especially high likelihood of exposure to AGS-20 because they are more likely than
other age groups to chew on textiles coated with it. The NRDC stated that had the EPA properly
taken infants into account, application of its own risk criteria “would have shown that AGS-20 poses
unacceptable risks, and thus may have unreasonable adverse effects.” The NRDC further argued
that the EPA likewise failed to consider the risk of aggregate exposures from other nanosilver on
the market. Had it done so, the NRDC stated, the EPA's analysis would have shown that register-
ing AGS-20 created unacceptable risks. NRDC concluded that, because the EPA's finding of no
*
Pesticides: Policies Concerning Products Containing Nanoscale Materials, 76 Fed. Reg. 35383 (June 17, 2011) (to be codi-
fied at 40 C.F.R. Chap. 1), https://federalregister.gov/a/2011-14943.
