McKenna Long & Aldridge’s (MLA) combined experience in regulatory policy within environmental and public health, our international perspective, and our substantive knowledge of emerging technologies particularly suit us to the newly developing regulatory landscape for nanomaterials. Our practical application as well as our expansive understanding of the ranging industries and products not only applies across many of the firm’s traditional practice areas, but also directly applies specifically to the nanotechnology space, which has broad application across products and industrial processes ranging from industrial “chemical” uses to cosmetics, food additives, pesticides, pharmaceuticals, and medical devices.
Over the last decade, governments and industry have been heavily investing in nanomaterials and related applications development. This investment has begun to create a “perfect storm” of nanomaterial uses in products hitting multiple investment and regulatory policy points even as changes in basic legislation and regulation are being considered and enacted.
Risk assessment and regulatory policy are being assessed and revised through legislation and guidance as more nanomaterials derived from the new technologies reach regulatory and safety assessment decision points. These assessments and revisions are happening at federal, statutory, and international levels creating a challenging landscape of policy evolution and compliance.
Regulatory and Public Policy
Our ability to customize public sector strategies to resolve our clients’ issues with government, and to identify opportunities that will positively impact their bottom line, attests to our relationships with policy makers. Our clients range from multinational corporations to non-profit organizations. We represent international governments with issues pending before the U.S. Congress and federal agencies, as well as local governments across the country seeking assistance at the state or federal levels of government. We work with clients to design legislative strategies that will have the greatest impact on policy makers.
We skillfully navigate the traditional regulatory processes for product authorizations in situations of evolving science and regulatory policy. Our attorneys and senior policy advisors for emerging technology translate current understanding of regulatory policy and science for client needs, and provide the following:
- Compliance support and strategies for chemicals, pesticides, food additives, and medical products as legislation and regulations are adapted to cover nanomaterials;
- Advice on brand protection as well as tort action avoidance and defense in the face of developing understanding of toxicity data and toxicity testing;
- Advice on technology acquisition with respect to regulatory policy development; and
- Advocacy within regulatory policy development at agencies on behalf of clients facing potential regulatory action or seeking regulatory approval.
Regulatory actions across governments are also inter-dependent as understanding improves in one region, regulatory approach, or constituency and finds its way to others. MLA understands these competing inter-dependencies and counsels clients in effective resolution of their dampening effects on businesses. Confusingly different and costly compliance pathways in the global market are mitigated, and barriers to trade addressed through foresight and action. MLA provides transnational, specific, and leading-edge experience to clients navigating the changing international regulatory and public perception for products.