The June 9 Federal Register included three important documents related to nanotechnology: a policy statement applicable to all agencies; an EPA options paper seeking comment on possible approaches to regulating nanotechnology in pesticides; and FDA draft guidance outlining its "current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology." The coordinated release of these documents provides insights into the government's thinking on nanotechnology issues. It also provides a valuable opportunity for input from industry and other stakeholders. Please review the analysis below and seriously consider submitting comments.

Policy Framework. "Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials"1 was issued by the Executive Office of the President (EOP), and was coordinated among the White House Office of Science and Technology Policy (OSTP), Office of Management and Budget (OMB), and Office of the United States Trade Representative (USTR). It establishes an overarching framework by which the federal government can promote a "balanced, science-based approach to regulating nanomaterials."2 This document is not open to comment and does not create any rights for private parties. Rather, it is intended to guide federal agencies in developing approaches to regulation of nanotechnologies.

The document directs agencies to use flexible, science-based approaches that examine "characteristics and properties of a material that ... present issues of potential regulatory relevance" as well as avoid "making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful."3 Furthermore, EOP requires the regulatory agencies to 4:

  • "base their decisions on an awareness of the potential benefits and the potential costs of such regulation and oversight,"
  • "strive to reach an appropriate level of consistency in risk assessment and risk management,"
  • "mandate risk management actions appropriate to, and commensurate with, the degree of risk identified," and
  • "seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues."

To help coordinate the approach and achieve the White House vision, OSTP, OMB, and USTR will establish a working group that will choose "terminology relevant to the regulation and oversight of nanomaterials" and that will "enable the relevant regulatory agencies to remain involved in and influence ongoing research."

This US policy initiative appears to have been coordinated with the European Commission, which plans to announce several nanomaterials policy decisions by the end of June 2011. Specifically, the Commission has pledged to recommend a definition of the term nanomaterials; to release the conclusions of three REACH implementation projects on nanomaterials; and to release a study on development of an inventory of nanomaterials and products containing them. Once these are released, the public can see whether there has been effective coordination between the United States and the European Union concerning the chosen policies in this important emerging area of regulation.

Alternative FIFRA Regulatory Approaches. The second document in the package is a request for comment from the EPA on three alternative approaches to regulating nanomaterials contained in pesticides. 5

The first approach involves using FIFRA's requirement to report adverse effects to "obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects in humans and the environment." EPA also intends to follow the existing regulation at 40 CFR 152.50(f)(3) to "require the inclusion of such information with any application for registration"6 as part of this approach. EPA claims it is appropriate to use this authority because "once the Agency has informed registrants that EPA considers a particular type of information relevant to determining whether a pesticide has the potential to cause unreasonable adverse effects on the environment, that type of information becomes reportable under FIFRA 6(a)(2)."7 Failure to report relevant information under FIFRA 6(a)(2) would constitute a violation per Sections 12(a)(2)(B)(ii) and 12(a)(2)(N).

The second approach on which EPA seeks comment is for the Agency to issue a "data call in" requiring disclosure of nanoscale materials in registered pesticides. If EPA selects this approach, then inclusion of information on presence of nanoscale materials and their potential effects would be required with any application for registration. EPA seeks comment on whether the existing statute will support this approach or whether FIFRA would require amendment to "clarify that this information is required with any application."8 In addition, it is important to note that data call ins can only be issued to registrants, not applicants, and unlike the 6(a)(2) option, it could require the registrant to generate or obtain data it does not already possess. Failure to respond to a data call in is considered a violation of FIFRA and can lead to suspension of registration.

Finally, EPA proposes a case-by-case determination through which some nanoscale active or inert ingredients could be deemed "new" under FIFRA. The Agency proposes "to apply an initial presumption that active and inert ingredients, which are the nanoscale versions of non-nanoscale active and inert ingredients already present in registered pesticide products, are potentially different from their conventionally sized counterparts."9 Additionally, EPA "also proposes to apply an initial presumption that nanoscale active and inert ingredients are potentially different even from other, already-registered nanoscale versions of the same ingredient. The Agency goes on to state that rebuttals to the presumptions can be accomplished on a case-by-case basis through submittal of additional data or through "data bridging."

The official version of the EPA proposal shall be published in the Federal Register soon and will be given a public comment period of 30 days (see Docket EPA-HQ-OPP-2010-1097 at http://www.regulations.gov).

FDA Draft Guidance on Nanotechnology. The final document in the package is an FDA draft guidance document titled "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology."10 The draft guidance is intended for industry and sums up FDA's current thinking with regard to what criteria it considers when determining if FDA-regulated products "contain nanomaterials or otherwise involve nanotechnology."11 The guidance does not establish any legally enforceable responsibilities or official regulatory definitions, and is likely to be accompanied in the future by "additional guidance documents to address considerations for specific products or classes of products." Availability of this guidance for public comment was announced in the June 14 Federal Register. FDA's draft guidance (see Docket FDA-2010-D-0530) will be open for public comment for 60 days, with comments due by August 15, 2011.

Preliminary Observations. One striking aspect of this coordinated publication is the differences among the positions taken by the three Agencies. This is particularly true with respect to the chosen "definition" of nanomaterials.

The Office of Pesticide Programs (OPP) defines 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." However, EPA goes on to note that it believes there is "no bright line with respect to a size below (or above) which nanoscale materials do (or do not) exhibit properties that might be of interest"12 and, thus, EPA might adjust the "precise size range in nanometers" (i.e., 1 to 100) in the future as new information becomes available. FDA also recognizes this "absence of a bright line" in its guidance and uses this to justify 1,000 nm "as a reasonable [upper] parameter for screening materials which exhibit properties or phenomena attributable to a dimension(s) above the approximate 100 nm range for further examination." Indeed, under the considerations of FDA the size range alone may not be sufficient to conclude whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology. Rather, it has to be observed whether "an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range." Importantly, these considerations apply not only to new products, but "also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components."13

The definitions on which EPA and FDA seek comments are not consistent. EOP commented that "[a] focus on novel properties and phenomena observed in nanomaterials may ultimately be more useful than a categorical definition based on size alone." The FDA draft goes a long way to implement this interpretation; however, EPA specifically excluded this commonly used aspect of the nanomaterial definition "because of the high degree of subjectivity involved with interpreting such phrases as 'unique or novel properties' or 'manufactured or engineered to take advantage of these properties.'"14 The Agency concludes that "[t]hese elements do not work in a regulatory context."

It is important that industries developing nanotechnology applications, or applications that may be swept up into expansive definitions of nanotechnologies, take full advantage of the opportunities to comment on both the EPA regulatory options and the FDA's draft guidance. While the options EPA published for comment apply only to pesticides, the policy choices that underlie any decision may also apply to general chemical regulation under TSCA, and under other EPA regulatory programs. The fact that EPA and FDA are proposing different approaches provides an opportunity to provide views on whether consistency is worthwhile. The time period for submitting comments on both documents is very short. We believe all potentially affected stakeholders should take advantage of these comment opportunities, and hope that industry will encourage the federal government to develop a rational risk-based approach to regulation across all agencies. We will be happy to coordinate comments from among our clients to maximize effectiveness and minimize cost.

Footnotes

1. See http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

2. Id. At 2.

3. Id. At 3.

4. Id. At 4.

5. General description may be found at http://www.epa.gov/pesticides/regulating/nanotechnology.html. The full prepublication notice is available at http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf.

6. See P. 1 of the EPA prepublication notice.

7. See P. 12 of the EPA prepublication notice. Also, see 40 CFR 159.95(c).

8. See Pp. 26-27 of the EPA prepublication notice.

9. See P. 30 of the EPA prepublication notice.

10. See http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm.

11. See 76 Federal Register 34715; June 14, 2011.

12. See P. 20 of the EPA prepublication notice.

13. See http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm.

14. See Page 14 of EPA prepublication notice.

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