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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > IATP Report Critical of Development of Nanotechnology Products with Inadequate Regulatory Oversight

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, "despite myriad uncertainties about the public health and environmental effects of ENMs." According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as "a small, but encouraging first step towards regulation."

August 4th, 2011

IATP Report Critical of Development of Nanotechnology Products with Inadequate Regulatory Oversight

The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, "despite myriad uncertainties about the public health and environmental effects of ENMs." According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as "a small, but encouraging first step towards regulation." See http://www.iatp.org/files/2011.6.29%20AgriNanotech%20SS.pdf

Of course, EPA's proposed nanopesticide policy issued on June 17, 2011, (76 Fed. Reg. 35383) expresses EPA's preference for an interpretation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) that is anything but "voluntary." EPA has proposed to use FIFRA Section 6(a)(2) as a vehicle to collect information concerning registered pesticide products with nanoscale active or inert ingredients (nanopesticides). Many in the pesticide community believe this approach is improper because it would effectively make substantive amendments to the existing promulgated regulation implementing FIFRA Section 6 (a)(2) in the guise of a less formal interpretation.

Similarly, many believe that the proposal to collect information through an interpretation of the current Section 6(a)(2) rule would improperly stigmatize pesticides containing nanoscale materials, and that EPA's statements that it does not intend for this to occur would be ineffective in preventing this result. Also, the fragmentary information that may be submitted would not, many believe, provide a coherent basis for formulation or implementation of EPA policies concerning the registration of pesticides with nanoscale ingredients.

EPA's proposal contains an alternative, specifically to use its Data Call-In (DCI) authority under FIFRA Section 3(c)(2)(B). Many believe this provision could provide a sensible starting point for the collection of information on nanopesticides. Unlike the proposal to collect information on nanopesticides using FIFRA Section 6(a)(2) submissions, EPA can collect information under FIFRA 3(c)(2)(B) in a manner that is probative, equitable, and non-discriminatory. Use of DCIs would also eliminate the perverse incentive for registrants to avoid useful research on pesticide composition that is intrinsic to any policy that relies upon Section 6(a)(2) submissions.

In light of the release in June 2011 of the White House principles on nanotechnology, and given the current state of scientific knowledge and the continued evolution of nanotechnology policy globally, many believe that it is premature for EPA to consider amending its pesticide registration guidelines for supporting data to establish specific testing requirements for nanopesticides. EPA has also requested comment on this concept in the proposed policy. EPA's coordination with on-going international initiatives is essential to ensure that any forthcoming testing and related requirements are harmonized, as urged in the White House memorandum on nanotechnology principles.

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