In June 2011, several federal agencies issued policy guidance documents regarding the regulation of nanomaterials. Although the guidance documents were issued by several different agencies, including the Office of Management and Budget, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), they all convey the need to strike a careful balance between protecting human health, welfare, and the environment while fostering regulatory certainty for businesses on the forefront of innovation of nanomaterials and nanotechnology. The guidance documents issued by FDA and EPA were published in draft form, and public comments must be submitted by August 15, 2011, and July 18, 2011, respectively.
Overarching Policy Principles Guidance
On June 9, 2011, the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the United States Trade Representative issued a joint guidance document entitled, “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” (Policy Principles Guidance). See http://tinyurl.com/4xcem3a. The Policy Principles Guidance document is intended to promote a balanced, science-based approach to regulating nanomaterials in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation.
The Policy Principles Guidance states that federal agencies will:
- Ensure scientific integrity, base their decisions on the best available scientific evidence, separating purely scientific judgments from judgments of policy to the extent feasible
- Seek and develop adequate information with respect to the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available
- To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), develop relevant information in an open and transparent manner, with ample opportunities for stakeholder involvement and public participation
- Actively communicate information to the public regarding the potential benefits and risks associated with specific uses of nanomaterials
- Base their decisions on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making
- To the extent practicable, provide sufficient flexibility in their oversight and regulation to accommodate new evidence and learning on nanomaterials
- Consistent with current statutes and regulations, strive to reach an appropriate level of consistency in risk assessment and risk management across the federal government, using standard oversight approaches to assess risks and benefits and manage risks, considering safety, health, and environmental impacts, and exposure mitigation
- Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment
- Seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with nanomaterials
- Encourage coordinated and collaborative research across the international community and clearly communicate the regulatory approaches and understanding of the United States to other nations
The Policy Principles Guidance envisions that compliance with these principles can be achieved under the existing regulatory framework for various agencies, and will not supersede existing agency authority. However, the Policy Principles Guidance does acknowledge that if agencies find that existing frameworks are insufficient to gather information regarding the possible risks of nanomaterials, then agencies should explore other methods to obtain the information necessary to properly assess potential risks and harms.
The Policy Principles Guidance applies to nanomaterials that are 1 to 100 nanometers in size, as well as those materials where the design of the material gives it unique properties that enable novel applications. The Policy Principles Guidance asks federal agencies to consider the novel properties of nanomaterials rather than to limit information gathering based on the size of materials. This broad definition of nanomaterials is intended to encompass the properties and attributes that emerge in nanomaterials which result in applications that may alter the safety, effectiveness, performance, or quality of products, and may give rise to both risks and benefits.
The Policy Principles Guidance cautions that federal agencies should avoid making unfounded generalizations that are not supported by science. Nor should agencies categorically judge all applications of nanotechnology as intrinsically benign or harmful. The goal of the Policy Principles Guidance is to build consumer trust and confidence in a sound regulatory regime in order to foster innovation and promote the responsible development of nanomaterials.
FDA also released a draft guidance document in early June entitled, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.” (FDA Nano Guidance). See http://tinyurl.com/3d2qp5n. The purpose of the FDA Nano Guidance is to help the industry identify when to consider the possible regulatory status, safety, effectiveness, or public health issues that could arise from the use of nanomaterials or nanotechnology in FDA-regulated products. The guidance also is intended to create a regulatory scheme that will address and answer any questions about nanomaterials or nanotechnology in FDA-regulated products. The underlying principles of this guidance document are consistent with those in the Policy Principles Guidance, and relate to the need to balance scientific advances and innovation with protection of human health. FDA acknowledges that use of nanomaterials or nanotechnology may result in a specific product having attributes that are different from a conventionally manufactured product. However, FDA does not categorically consider products containing nanomaterials or using nanotechnology to necessarily be either intrinsically harmful or benign.
The majority of the FDA Nano Guidance is focused on what type of material is considered “nano.” Like other federal agencies, FDA does not have a regulation defining nanomaterial, nanoscale, or nanotechnology. As a result, the FDA Nano Guidance asks industry to consider two points: 1) whether an engineered material or end product has at least one dimension in the nanoscale range (1 to 100); and 2) whether an engineered material or end product exhibits properties or phenomena that are attributable to its dimensions, even outside of the nanoscale range up to 1 micrometer. FDA provides detailed descriptions for the key terms, including “engineered material or end product,” “at least on dimension in the nanoscale range (approximately 1 nm to 100 nm),” “exhibits properties or phenomena . . . that are attributable to its dimension(s)” and “size range up to 1 micrometer (1,000 nm).” Asking industry to consider both the size of particles as well as other elements, including function, shape, charge, ratio of surface area to volume, or other physical and chemical properties, is consistent with the Policy Principles Guidance.
The FDA Nano Guidance states that the FDA premarket review process is a good opportunity for FDA to learn more about the use of nanomaterials in products. The guidance also provides that where no premarket review is required, FDA still urges manufacturers to consult with the agency early in the product development process regarding uses of nanomaterials in products.
The FDA Nano Guidance is still in draft form, and comments may be submitted to the agency through August 15, 2011.
The EPA draft guidance, entitled “Policies Concerning Products Containing Nanoscale Materials” (EPA Nano Guidance). See http://tinyurl.com/3srap5v. EPA Nano Guidance addresses the use of nanomaterials in pesticide products. In recent years, EPA has taken initial steps towards regulating nanomaterials under the Toxic Substances Control Act (TSCA). The current guidance does not involve TSCA, but rather the narrower regime of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The draft guidance document is similar to the FDA Nano Guidance in that EPA also is seeking to collect information regarding the use of nanomaterials in pesticide products, and proposes to achieve this in one of two ways, as discussed below. EPA will use the EPA Nano Guidance to seek out information about both active and inert ingredients in pesticides.
The first alternative that EPA proposes is to use the agency’s authority under Section 6(a)(2) of FIFRA to obtain information about what nanoscale material is present in a registered pesticide product and its potential effects on human health or the environment. Section 6(a)(2) of FIFRA requires pesticide registrants to submit to EPA any additional factual information regarding unreasonable adverse effects of a registered pesticide. EPA broadly interprets the term “unreasonable adverse effects” to include both direct and indirect possible adverse effects. Under this approach, applicants for new or follow-on pesticide registrations also would be required to submit any information about possible adverse effects from nanomaterials in pesticides.
EPA states in the preamble to the guidance that this is the agency’s preferred approach because it is the most efficient and expedient way to obtain the information the agency seeks. This is because compliance with Section 6(a)(2) of FIFRA is self-implementing and puts the burden of identifying and submitting information on the registrant or the applicant, rather than on the agency. However, pesticide registrants are concerned about the possible stigma associated with requiring information on nanomaterials in pesticides under EPA’s adverse effects authority.
The alternative approach that EPA is considering is to collect the information through the data call-in (DCI) notice process provided for in Section 3(c)(2)(B) of FIFRA. If EPA adopts this alternative, it would need to send a request to each registrant from which it is seeking data about the use of nanoscale materials in pesticide products. When sending a DCI notice, the agency can request data that a registrant already has in its possession, and may also require a registrant to conduct further studies and compile additional data to respond to the request. If a registrant fails to respond to the DCI, EPA may use this failure as the basis for suspending the registrant’s pesticide registration.
Although EPA may be able to seek additional data through the DCI approach, it is not a self-implementing process and would require the agency to take the initiative and expend the resources to prepare, send, and review the responses to the DCI. In addition, EPA acknowledges that if it adopts this approach it may need to amend its regulations to ensure that applicants for new or follow-on registrations are included within the scope of the regulations. Although this approach will be more time intensive for the agency, this is the approach likely to be favored by industry since it puts the burden to request the information on EPA.
Unlike the broad definition of nanoscale materials under the Policy Principles Guidance and the FDA Nano Guidance, EPA intends to use a more objective definition of nanomaterials. Under the EPA Nano Guidance, the policy will only apply to any active or inert ingredient that is intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.
EPA is accepting comments on the draft guidance through July 18, 2011.
For the time being, it appears that the federal government intends to use its existing authority to gather information on the use of nanomaterials in federally regulated products, including foods and pesticides. However, industries and companies that will be affected by either the FDA or EPA Nano Guidance documents should be thoughtful of the long-term regulatory and policy implications of the information that the government intends to gather. To that end, those that will be affected by the FDA or EPA Nano Guidance may want to consider filing comments on the draft proposed regulations.
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Sarah A. Slack
Michael D. Flanagan
J. Steven Rutt