Comments Submitted in Response to the Proposed Rule on Pesticides; Policies Concerning Products Containing Nanoscale Materials

Comments Submitted in Response to the Proposed Rule on Pesticides; Policies Concerning Products Containing Nanoscale Materials

The Environmental Protection Agency ("EPA" or "Agency") solicits public comments about what procedures it should use to obtain more information on the use of nanoscale ingredients in pesticide products. 76 Fed. Reg. 35383 (June 17, 2011, hereinafter "Proposed Rule"). The Agency asks whether its authority to obtain information on the use of nanoscale ingredients most appropriately arises under § 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA" or "Act'), drawing upon the Agency's authority to collect additional information connected to adverse effects, versus § 3(c)(2)(B) using the Agency's Data Call-In or "DCI" approach. Id.

The authority under § 6(a)(2), as stated by the statute itself, is for reporting adverse effects information. EPA has other authority under other provisions of the Act to gather information about developing science. There are several reasons why the proposed use of § 6(a)(2) authority to require submission of routine information on particle size and the like is troublesome. As an initial matter, the agency has not sufficiently demonstrated how adverse effects could follow from the information that it proposes to collect due to the use of specific pesticide products or pesticide products in general. EPA's proposal would establish a harmful precedent for requesting routine information for any other pesticide ingredients through the § 6(a)(2) mechanism, which is contrary to its limited purpose. The expansion of authority that EPA is seeking to invoke goes beyond the explicit language of the statute, defies Congressional intent, and does not warrant agency deference for this reason and due to the numerous other authorities FIFRA provides EPA for information collection. In addition, it not in the public interest to make a blanket pronouncement on relative safety of any pesticide ingredients in advance of careful study, and doing so undermines EPA's scientific reputation.

The agency's legal position seems to be that the implementing regulations for § 6(a)(2) obligate registrants to report "information not explicitly covered under the § 6(a)(2) 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 (40 CFR 159.195)." 76 Fed. Reg. at 35390. Nevertheless, this authority has to be read in the limiting context of the statute. The plain text of FIFRA § 6(a)(2) states: "if at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to [EPA]." 7 U.S.C. § 136d(a)(2) (emphasis added). In our view, EPA cannot suggest that it is "merely identifying a set of information [e.g., identity and description of nanoscale ingredients] that adds to the subset of reportable section 6(a)(2) data explicitly identified at present under the section 6(a)(2) regulations" without making the explicit finding that this is information "regarding unreasonable adverse effects", a finding that the agency claims to stop short of in this proposal. Id. Section 6(a)(2) of FIFRA simply does not permit EPA this latitude. Despite the agency's protests to the contrary, this proposal must be viewed as a bold and sacrificial move that eliminates any possibility for an impartial agency review.

The agency is asking whether the information it seeks on the use of nanoscale ingredients should be sought, alternatively, through DCI notices pursuant to FIFRA § 3(c)(2)(B). EPA could obtain information concerning nanomaterials in pesticides by issuing a DCI to existing pesticide registrants, directing them to provide data "required to maintain in effect an existing registration of a pesticide." FIFRA § 3(c)(2)(B). We think this approach certainly improves upon the use of § 6(a)(2) for achieving EPA's desire to obtain information while acknowledging the current level of scientific knowledge, consistent with the kind of regulatory neutrality that should be associated with this kind of information collection activity. We respectfully encourage EPA to continue to develop its thinking along these other information gathering lines.

In addition, EPA is asking for comments on what we will refer to in our comments as the "new ingredient presumption" for nanoscale pesticide chemicals. Pesticides may not be sold or distributed into the United States unless they are registered with EPA pursuant to FIFRA § 3. EPA registers products once it has evaluated the risks and benefits of a pesticide product to ensure that the product will not cause "unreasonable adverse effects on the environment," and, for products whose use may result in pesticide chemical residues in food, that there is a "reasonable certainty of no harm" from the use of the product. EPA is now proposing to regulate nanoscale ingredients in pesticides using a "rebuttable presumption" that active or inert nanoscale materials will be processed as "new" ingredients. 76 Fed. Reg. at 35392. EPA would then place the burden on the registrant to show, through submission of bridging data or other information on the nanomaterial's properties relevant to assessing risk to human health or the environment, that the already-registered non-nanoscale or already-registered nanoscale form of the material are similar to the substance seeking to be registered.

We think that EPA has not made a sufficient case to depart comprehensively from existing practice in this proposal and that any changes must be grounded in the existing regulations and definitions for FIFRA. While rebuttable, the "new ingredient presumption" is a significant departure from formal EPA registration requirements that focus primarily on chemical composition (and never before on particle size) as the attribute relevant to making "new" active or inert ingredient determinations. While the agency is given significant authority under FIFRA to protect environment and public health, it has not established a sufficient basis in this proposal to warrant this degree of regulatory barrier. Nor does EPA propose to instruct registrants on how to measure or report on particle size in this proposal, which must be well thought out from a technical and scientific perspective. EPA's proposal does not specify the quantity that is sufficient to qualify a product as a nanoscale ingredient. EPA's proposal is therefore arbitrary and capricious and does not warrant deference given alternative authority that the agency has through registration review and through amending its data requirements to consistently require information on particle size distribution as part of the registration process.

Any approach EPA takes should comport with the public policy articulated in the White House's Policy Principles on Emerging Technologies in its ability to present a neutral request for information that does not presuppose the information being requested indicates that the pesticide product is "inherently dangerous or benign." EPA acknowledges the potential, significant benefits that nanoscale materials may contribute to pesticides. EPA acknowledges that neither the scientific community nor EPA can determine whether a substance used with nanoscale properties has a negative, positive, or neutral impact on the product and its intended use. Yet EPA is prepared to call into question the fate of existing registered products which are being safely used and to stifle the innovation and development of new, beneficial products for the foreseeable future. The policies proposed are far beyond the pale of neutral in the overall continuum of pesticide regulation and we encourage the agency to further refine its approach.

Our suggestions are offered below in our responses to the agency's questions.  To read the complete comments, please access the Comments Submitted in Response to Proposed Rule on Pesticides: Policies Concerning Products Containing Nanoscale Materials

The khlaw.com web site is intended to provide information of general interest and is not intended to offer legal advice about specific situations or problems. Keller and Heckman LLP does not intend to create an attorney-client relationship by offering this information, and anyone's review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Keller and Heckman lawyer. However, unless you are a client, your e-mail is not privileged or confidential. Even if you are a client, remember that e-mail is not secure. Sensitive or confidential messages should be encrypted.

For more information about LexisNexis products and solutions connect with us through our corporate site.