Regulatory DevelopmentsJune 10, 2011
The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines "nanoscale material" as "an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm)." Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) "is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach." The notice also proposes a "new approach" that EPA will use to 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, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register. More information is available online.
According to the notice, "EPA believes that certain information concerning pesticide ingredients, which applicants and registrants have not routinely provided previously, is relevant to the Agency's statutory obligation to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment," and "EPA is particularly interested in nanoscale materials in this context." While EPA has not developed to date formal definitions for the terms "nanotechnology" or "nanoscale materials," "OPP will focus on more objective criteria in describing when information about a 'nanoscale material' in a pesticide product may be relevant to determining whether the product has an unreasonable adverse environmental effect." Specifically, EPA states that such information may be relevant when the active or inert ingredient and any component parts thereof "is intentionally produced to have at least one dimension that measures between approximately 1 and 100 nm, regardless of the aggregation or agglomeration state of the final material." In determining whether an ingredient meets this description, EPA may review particle size data and, among other things, the manufacturing process to determine whether it employs processes specifically to create or enhance the proportion of nanoscale materials in the product, as compared with other processes used to produce similar products. EPA "generally expects that these ingredients may comprise, but are not limited to, metal-based (e.g., silver) and carbon-based (e.g., carbon nanotubes) nanoscale materials." EPA does not intend this description to cover biological materials or materials in their natural state (e.g., clays).
EPA believes that any of the following types of information are relevant to assessing the potential of a pesticide to cause unreasonable adverse effects on the environment, but notes that this is not an exclusive list:
- Any information concerning what nanoscale materials are present in pesticides, whether as an active ingredient or as an inert ingredient;
- For any pesticide product that contains nanoscale material, whether active or inert, any existing information that characterizes the size and size distribution of the nanoscale material as measured in nanometers;
- For any pesticide product that contains nanoscale materials, whether active or inert, any existing information that describes the manufacturing process used to produce the nanoscale material in whatever size range it is produced;
- For any pesticide product that contains nanoscale materials, whether active or inert, and that also is or will be used for an end-use formulation that contain(s) a composite (e.g., the active ingredient is a matrix complex comprised of the nanoscale material(s) in combination with a carrier, such as silica or sulfur), any existing information that characterizes the size and size distribution of the composite; and
- For any pesticide product that contains nanoscale materials, whether active or inert, any existing information that shows adverse effects at any level of exposure to the nanoscale material on humans or nontarget species, and/or that shows the levels or nature (e.g., routes, frequency, or life stage) of potential human and environmental exposure.
FIFRA Section 6(a)(2)
Under FIFRA Section 6(a)(2), pesticide registrants must report certain information if that information: (1) is additional; (2) is factual; and (3) regards unreasonable adverse effects on the environment of the pesticide. Per 40 C.F.R. Section 159.195, this includes information that, if correct, a registrant knows, or reasonably should know, would be regarded by EPA, either alone or in conjunction with other information about the pesticide, as raising concerns about the continued registration of a product or about the appropriate terms and conditions of registration of a product. EPA states that announcing the applicability of FIFRA Section 6(a)(2) to information about nanoscale materials in pesticides "would not mean that EPA is expanding its interpretation of FIFRA section 6(a)(2) or changing its regulations." Instead, "EPA would be merely identifying a set of information that adds to the subset of reportable section 6(a)(2) data explicitly identified at present under the section 6(a)(2) regulations." EPA notes that the identification of information as reportable under FIFRA Section 6(a)(2) "does not mean that any particular pesticide or group of pesticides, to which such information pertains, poses a risk," but rather, "merely indicates that EPA has determined that a particular type of information is relevant to, and may improve the Agency's ability to assess, whether the pesticide would cause an unreasonable adverse environmental effect."
Under the FIFRA Section 6(a)(2) approach, EPA would also require that any such information be reported in connection with any application to register a pesticide product containing any nanoscale material. As with the reporting obligation, EPA would consider the failure to provide these types of information with an application for a product containing nanoscale material to be a violation of FIFRA. EPA regulations implementing FIFRA Section 6(a)(2) provide that a registrant must submit information to EPA that is reportable no later than the 30th calendar day after the registrant first possesses or becomes aware of the information. In addition, a registrant is required to submit to EPA any Section 6(a)(2) information not explicitly covered under the regulations if EPA has informed the registrant that such additional information has the potential to raise questions about the continued registration of a product or the appropriate terms and conditions of registration of a product.
EPA acknowledges that, after learning that EPA was considering relying on FIFRA Section 6(a)(2) to require reporting, some stakeholders raised questions about the use of Section 6(a)(2) to obtain this information. While EPA states that it is not making a judgment that the presence of any particular nanoscale material poses a risk, stakeholders have argued that use of the "adverse effects" reporting authority in FIFRA Section 6(a)(2) could create a "stigma" for the nanotechnology industry. EPA disagrees, and contends that its "longstanding interpretation" of Section 6(a)(2) is that it is not limited to requiring reporting only of actual "adverse effects" of pesticides, but instead "requires reporting of 'additional factual information regarding unreasonable adverse effects on the environment,' where 'unreasonable adverse effects on the environment' is specifically defined as a risk/benefit standard."
According to EPA, use of FIFRA Section 6(a)(2) would have only a minimal overall administrative burden for both EPA and industry. Only registrants who know that their products contain nanoscale materials would be required to report, and they would be required to report only the information they know about. EPA notes that Section 6(a)(2) does not require a registrant to generate new data or to seek out additional information. Registrants and applicants whose products do not contain nanoscale materials, or who do not know that their products contain nanoscale materials, would have no reporting obligation. Under this approach, EPA would be required to keep track of each response received under Section 6(a)(2), but would not otherwise need to prepare or track individual requests for the information.
DCIs under FIFRA Section 3(c)(2)(B)
As an alternative to relying on FIFRA Section 6(a)(2) to obtain information concerning nanoscale materials in pesticides, EPA is also considering issuing DCIs under FIFRA Section 3(c)(2)(B). EPA has authority under FIFRA Section 3(c)(2)(B) to issue a DCI notice to a pesticide registrant directing them to provide data "required to maintain in effect an existing registration of a pesticide . . ." The DCI notice is addressed to an individual registrant, specifically identifies the information or data that the registrant must provide, prescribes an initial response deadline of 90 days, and, if data are to be generated, it may prescribe a timeframe for generating and providing that data. Under FIFRA, EPA can suspend the registration of a pesticide if the registrant fails to respond to a DCI.
EPA states that, as part of this alternate approach, it would also need to require the inclusion of this information with any application for registration of a pesticide product that contains a nanoscale material. EPA is reviewing whether this could be done under existing regulations or whether it would need to amend existing regulations to clarify that this information is required with any application for registration. As with the reporting obligation under FIFRA Section 6(a)(2), EPA would consider the failure to provide these types of information with an application for a product containing nanoscale material to be a violation of FIFRA.
Since EPA's goal is to identify what nanoscale materials are contained in products, and the products that contain them, and to gather existing information not previously provided to assess their safety, the DCI would need to require specific kinds of information. EPA notes that, because such a request is not consistent with the Re-registration or Registration Review Programs, it would use the Enforcement and Unanticipated Circumstances category available in the currently approved Information Collection Request.
Unless a registrant has already disclosed the presence of nanoscale material in all of its products, EPA cannot identify with certainty what nanoscale materials are in products (and the products that contain them). Therefore, to identify what nanoscale materials are in products, EPA could initially send an individual Enforcement and Unanticipated Circumstances DCI order to each of the 1,716 currently registered pesticide producers. Under this approach, each of these pesticide registrants would then be required to respond within 90 days by either providing the requested information about the nanoscale materials in their product(s) or certifying that their product(s) do not contain nanoscale materials. In addition to keeping track of each response like under FIFRA Section 6(a)(2), the DCI approach could require EPA to also prepare and track the issuance of individual DCIs for each pesticide registrant, as well as determine and take any necessary enforcement actions for non-responders. EPA notes that only pesticide registrants receive DCIs; EPA would need to employ additional administrative procedures to ensure that applicants also provided such information.
EPA suggests that a variation on this approach would be to craft a DCI that would be more targeted and place less burden on industry and EPA, possibly by not requiring a response from recipients of the DCI who do not have (or who do not know that they have) nanoscale material in their registered pesticide products. EPA states that it has not used such an approach with any DCI in the past, however, and a number of issues, including enforcement, would need to be addressed if it were to seek to do so here. EPA could also focus its initial data gathering on certain classes of pesticides that might be most likely to contain a nanoscale material that EPA would be interested in knowing about. EPA requests comments on these variations.
EPA states that it is "useful to note" that while it can use FIFRA Section 6(a)(2) to obtain existing information, it could use the DCI approach to request that data be generated. If EPA uses its FIFRA Section 6(a)(2) authority and learns, for instance, the identity of a nanoscale material present in a product, and subsequently determines that sufficient data are not available to support the continued registration of the pesticide, EPA could then use the DCI approach to gather such information. EPA must use the DCI approach if EPA intends to require a registrant to provide information which the registrant does not already possess.
EPA anticipates some registrants will request that EPA review information to determine if their product contains nanoscale materials. To the extent that the description of nanoscale material to a particular product or ingredient is unclear, EPA states that it will review information concerning the composition and manufacturing process of the pesticide product and, based on that information, it will determine whether the product contains nanoscale material.
Under either the 6(a)(2) or the 3(c)(2)(B) approach, EPA states that, in the future, it will likely use DCIs targeted to individual pesticide products that contain specific nanoscale materials to collect more specific information or data about particular products. EPA would consider doing so on a case-by-case basis and would tailor any request for information accordingly.
Amending the Pesticide Data Requirement Regulations
Some stakeholders have suggested, as an alternative to relying on either FIFRA Section 6(a)(2) or DCIs to obtain information concerning nanoscale materials in pesticides, that EPA instead promulgate a regulation amending the data requirements in 40 C.F.R. Parts 158 and 161. EPA could amend the data requirements to include disclosure of what nanoscale materials are present as part of the pesticide registration process. EPA notes that completing this action would not provide information on currently registered pesticide products, however. Although it could take considerable time to implement a rule establishing standard data requirements for pesticides containing nanoscale materials, and EPA thus believes that this approach by itself would not generate information in a timely manner, EPA requests comment on this approach.
Proposed Policy Regarding Classification of Applications under FIFRA and PRIA for Products Containing Nanoscale Active and Inert Ingredients
EPA 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 those conventionally sized counterparts. 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 ingredients. For purposes of registration under FIFRA Section 3(c)(5) or 3(c)(7), therefore, EPA would initially classify any application for registration of a pesticide product containing an active or inert ingredient that is a nanoscale material as an application for a "new" active or inert ingredient, even when another registered pesticide product contains a non-nanoscale form of the ingredient or a nanoscale form of the ingredient with different size dimensions or other properties. Registrants could rebut this initial presumption, however, on a case-by-case basis through the submission of bridging data or other information demonstrating to EPA's satisfaction that the nanoscale material's properties, which are relevant to assessing the potential risks to human health and the environment, are substantially similar to the properties of the already-registered non-nanoscale or already-registered nanoscale form of the material, or that the nanoscale material differs only in ways that do not significantly increase the risk of unreasonable adverse effects on the environment, and that approving the registration in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment. According to EPA, if an applicant could make this showing to EPA's satisfaction, then EPA would process the application as a "me-too" application within the timeframes prescribed for such applications. If an applicant could not make this showing to EPA's satisfaction, however, then EPA would process such products as new active ingredients or new inert ingredients and would complete its review within the timeframes prescribed for such applications. In those circumstances, EPA states that it would likely require the applicant to provide the types of data typically required for an assessment of the potential hazards and exposure to a new active or inert ingredient. Under this proposed policy, it would also follow that if a registrant wished to change the composition of its product to include a nanoscale version of a material that EPA had previously approved in non-nanoscale form, the registrant would need to notify EPA and obtain EPA approval before making such a change in the composition of its product. EPA notes that the registration status of a product would not change merely as a result of providing information to EPA about the presence of a previously-unreported nanoscale material, however. If EPA made an affirmative finding that a change in status or conditions of use was necessary, EPA would notify the registrant in accordance with applicable regulations and procedures.
Questions for Comment
EPA specifically invites comments on the following issues:
- In view of EPA's goal of identifying what nanoscale materials are in products so that EPA can determine whether it needs additional data to evaluate the products' safety under FIFRA, should EPA change the description of a "nanoscale material"?
- Should the reporting requirement apply only to nanoscale material that is "intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers," or should it also apply to naturally occurring materials?
- Is the meaning of "intentionally produced" sufficiently clear? Would offering a consultation procedure -- by which a registrant or applicant describes to EPA the production process that results in the presence of a material in the nanoscale size range, and EPA responds with a determination regarding whether reporting is required -- be an acceptable approach to providing clarity?
- Should the reporting requirement apply to ingredients in pesticides that contain any amount of a nanoscale material, or should the requirement apply only if an ingredient contains more than a specified percentage (e.g., 10 percent) of nanoscale material? If the latter, what should the specified percentage be and why?
- How should the reporting requirement apply to a pesticide manufacturer who purchases ingredients that may contain nanoscale material?
- Are there ways in which the description of "nanoscale materials" can be refined and clarified, including ways in which agglomeration and aggregation could be considered as well as suggestions for ways in which more subjective criteria, such as "unique or novel properties" can be incorporated into the screening criteria?
- Is EPA's description of "nanoscale material" inconsistent with other definitions of nanoscale material or similar terms? If so, please comment on whether such differences create any regulatory issues. In particular, does the focus on "intentionally produced" materials create any such inconsistency with other definitions of nanoscale materials or similar terms?
- If a pesticide is identified as containing a particular nanoscale material, what would be the most useful next steps to inform EPA's understanding of potential risks associated with the pesticide? Are there tests that could provide useful information toward an understanding of risk that would be common to all nanoscale materials, or should the data requirements necessarily be compound- and situation-specific? How should bioavailability be considered in determining testing requirements (e.g., are nano-particles respirable or bound to other components)?
With respect to the proposed approaches, EPA seeks comment on how to implement them to ensure efficient, effective, and timely review of applications. EPA specifically invites comments on the following issues:
- Is there a way to determine, in advance of receiving an application for registration of a product containing a nanoscale material, whether a particular kind of nanoscale material has properties that, for purposes of risk assessment, are essentially the same as larger sized materials of the same substance? If so, how would such determinations be made and on what would they be based?
- What kinds of information should EPA accept as demonstrating that a pesticide product containing a nanoscale ingredient is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and that approving the registration in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment?
- Can you suggest any alternative(s) to the proposed approaches that would be equally or even more effective in addressing the status of nanoscale materials as new active or inert ingredients for purposes of both FIFRA and PRIA, keeping in mind the data showing that size, especially when reduced below approximately 100 nm, may alter the manner in which materials behave and, in turn, the potential risk to human health and the environment associated with such materials?
With respect to the potential alternative ways of obtaining the needed information on what nanoscale materials are in pesticide products, EPA specifically invites comments on the following issues:
- Has EPA appropriately characterized in this document the current scientific understanding of the potential risks of nanoscale materials? If not, please comment on how to characterize the potential risks of nanoscale materials. How would the perception of the risks of nanoscale materials differ depending on the approach used by EPA to require needed data on nanoscale materials in pesticides? How could EPA lessen the possibility that issuance of a final requirement to report what nanoscale materials are in pesticides will result in a public misunderstanding of the potential risks of nanotechnology more generally?
- Do commenters believe that identification of the nanoscale materials in pesticide products is relevant to EPA's statutory determination regarding the potential for unreasonable adverse effects on the environment? Please provide the scientific or legal basis for your view.
- Has EPA characterized the alternative approaches with respect to which they would: (a) result in a misunderstanding of the potential risks posed by nanoscale materials; (b) result in the timely submission of needed information; and (c) impose burdens on pesticide companies, those whose products do, and do not, contain nanoscale materials? If not, please comment on those issues.
- If EPA uses FIFRA Section 6(a)(2) to obtain the needed information on nanoscale materials in pesticides, how could it ensure that its action is not mischaracterized or misunderstood as a determination that the mere fact that a pesticide contains nanoscale materials causes unreasonable adverse environmental effects?
- If EPA were to use DCIs to obtain the needed information on nanoscale materials in pesticides, how could EPA reduce both the burdens on registrants and on EPA, as well as the time required to complete such a process? For example, is it possible to reduce the burdens on registrants by targeting only certain types of products? If so, how would EPA determine which products should receive DCIs?
- What are the advantages and disadvantages of requesting information on nanoscale materials specifically versus requesting information on size distribution generally? (Note that either type of information could be collected under either the 6(a)(2) or the 3(c)(2)(B) approach, except that 6(a)(2) cannot be used to require the production of new information that does not already exist, while a collection under 3(c)(2)(B) must be directed to an individual registrant and requires a response.) Is identifying what nanoscale materials are in products a useful first step, or should EPA move towards immediate collection of more specific information, such as particle size distribution, on products that might contain nanoscale materials? Are there other physical and/or chemical properties that might be equally or more important for assessing the potential of a pesticide to cause unreasonable adverse effects on the environment (e.g., morphology, including shape and crystal structure; surface chemistry and reactivity; specific surface area, charge; solubility; conductive, magnetic, and optical properties)? Should information on these properties be separately requested? What would be the value and burden of obtaining such information?
- If EPA were to use rulemaking to establish data requirements for pesticides containing nanoscale materials, what types of information should EPA use to determine appropriate data requirements? What types of studies should EPA require to evaluate a nanoscale material?
- When choosing an approach for obtaining needed data, how should EPA weigh considerations relating to the need to update its safety evaluations of currently marketed pesticides in a timely manner, the goal of ensuring marketplace equity, and the interest in minimizing the burdens on regulated entities?
The pesticide policy document is remarkable given the much enhanced discussion of the issues presented for comment and options presented. Long in gestation, the document represents a significant departure -- and considerable improvement -- over EPA's initial description of its intended "nano-pesticide," which appeared to reflect a pre-ordained approach to require Section 6(a)(2) reporting and disallow other options to obtain information under FIFRA that many believed more appropriate, including FIFRA Section 3(c)(2)(B) DCI approach.
The document reflects a much more nuanced and thoughtful articulation of what EPA hopes to achieve. Even with a stated bias in favor of EPA's original FIFRA Section 6(a)(2) approach, the list of issues and questions about which EPA invites public comment is an opportunity for the public -- industry advocates and public health and environmental advocates alike -- to weigh in on the substantive issues at hand.
As the pesticide industry vocally urged the DCI approach, among other options, as preferred alternatives to the Section 6(a)(2) approach, the policy document identifies issues that make the DCI alternative less than a straightforward equivalent. Given the comprehensive discussion of the issues presented, the notice opens the door for the registrant community to educate itself, EPA, and the public on the state of nanopesticides, what the technology means for the pesticide industry, and what reporting, registration, and other risk management options should apply to address potential risks derivative of nanoscale components of pesticide products, as well as how the benefits of nanopesticides should be identified, communicated, and nurtured.
In particular, the discussion of how best to avoid the "stigmatization" of pesticide nano-components as necessarily representing an adverse effect is a clear concession to the manufacturers of pesticides that forcefully raised significant concerns over EPA's initial assurances about its plans regarding implementing and communicating the Section 6(a)(2) reporting policy. Stakeholders have now been invited to participate in how to best approach this difficult issue. FIFRA registrants are urged to step up, meet the challenge, and comment coherently and cogently on the best way to proceed.
One last point would be to note the possible implications of the PRIA issues mentioned appropriately in the policy document. The PRIA category designation as a new chemical could result in a PRIA fee of almost a million dollars for any nano product declared as new and not "old" (me-too). The price distinction is obvious, but the underlying point is that policy determinations outside of PRIA driven by how EPA articulates a final policy for reporting or to define the parameters of its regulatory vigilance could have significant and far-reaching impacts on the development of the nanomaterials industry or the adoption of nanotechnologies in the pesticide industry. The notice is not silent in requesting comment on many of the important elements here, even as simply as what PRIA category should apply.
The point here is that more interest will likely be devoted to the broad issues of data reporting, "stigmatization," and appropriate controls, whereas the biggest impact a few years from now on nanopesticides may be driven by the PRIA fees imposed derivative of these more visible (and controversial) elements of the public debate today.
Given the breadth and significance of the issues, and the potential complexity, legal vulnerability, and burdens presented by the different options, it is essential for potentially affected entities carefully to consider the issues and approaches discussed and develop and offer strong, informed comment of a caliber comparable to the quality and thoughtfulness of EPA's notice. It will be important in this regard to recognize that the targets for the comments include both EPA and other federal agencies/OMB, that likely were influential shaping the contours of the policy. While comments may or may not sway EPA's views, they will be available for consideration by other agencies during the inter-agency review process. This fact underlines the importance of strong, well articulated, and informed comments that "make the case" for whatever perspective is offered and whatever option is preferred.