Environment & Product Regulation

Uniquely positioned to address the most nuanced environmental and consumer product issues facing businesses today, the Environment & Product Regulation Practice is deeply embedded in DC – and all of the agencies that our dynamic clients partner with.

Consumer products are among the most heavily regulated and scrutinized assets in the marketplace, but they are also one of the most revolutionary spaces for innovation on the national and global stage. This is where we thrive.

What we do.

Our multidisciplinary team comprises lawyers, consultants, and regulatory analysts who are ideally suited to assist with legal and business challenges across every single phase of the life cycle of a consumer product, including:

• Product development and premarket approval
• Sourcing, supply chain, and transactional support
• Manufacturing and materials
• Regulation and policy
• Compliance and enforcement
• Labeling
• Marketing and advertising
• Safety
• Transportation, import, and export
• Recalls and reverse distribution
• Product stewardship and recycling

We have particular environmental and product experience in a variety of industries, including:

• Batteries
• Chemicals
• Children’s products
• Household products
• Emerging technology (including biotechnology-based products and nanoscale materials)
• Packaging
• Pesticides (including antimicrobials and biocides)
• Plastics
• Products powered by small nonroad engines

Why we are different.

The practice additionally brings in-depth knowledge to such critical environmental matters as:

• Biotechnology, biofuels, and renewable energy
• Clean Air Act (CAA) and air emissions
• Climate change
• Endangered species
• Energy efficiency and sustainability
• Environmental regulation, litigation, and enforcement
• Occupational health and safety

We are dedicated to helping our clients navigate cross-cutting regulatory issues alongside some of the most powerful federal agencies in DC, as well as providing representation in regulatory and legislative matters at the state level. The agencies we work with include:

• U.S. Environmental Protection Agency (EPA)
• U.S. Department of Agriculture (USDA)
• U.S. Customs and Border Protection (CBP)
• U.S. Consumer Product Safety Commission (CPSC)
• U.S. Department of Transportation (DOT)
• Federal Aviation Administration (FAA)
• U.S. Department of Energy (DOE)
• Federal Energy Regulatory Commission (FERC)
• Federal Trade Commission (FTC)

For timely commentary on environmental and product regulation matters, visit The WELL, the Wiley Environmental Law Line. Our team knows how to get things done in DC and we use this blog to offer guidance on a range of issues in the federal policy space, empowering environmental professionals with the “what” and the “why” behind the most pressing product regulation and compliance topics facing our nation and our planet.

Biotech Briefings

TSCA and Industrial Biotechnology
June 2021
Martha E. Marrapese

When is a microbe or microalgae considered naturally occurring and when are they subject to EPA premanufacture review? What kinds of products produced by microbes and microalgae are subject to TSCA? Martha examines the basic TSCA framework, exemptions, and best practices for TSCA filings during this session.

U.S. Department of Agriculture – Plant Pests and Importation Part 330
March 2021
Martha E. Marrapese

Developers of certain genetically engineered plants benefited from limited regulatory relief in 2020 as USDA promulgated final amendments to the 7 C.F.R. Part 340 regulations governing interstate movement of certain genetically engineered plants. The movement of soil and non-genetically engineered microbes may still require permits under 7 C.F.R. Part 330. In this webinar Martha addresses the regulatory requirements applicable to non-GE microbes and microalgae.

Interim Update on Regulatory Developments Relevant to Plant Biostimulants
March 2021
Keith A. Matthews

2019 and 2020 saw significant action on the part of U.S. Federal agencies to work toward upgrading the regulatory structure applicable to plant biostimulant products. This webinar provides an update on where things stand and what the prospects are for further actions in 2021. As noted during the webinar, when EPA issues its final regulatory guidance impacting plant biostimulants regulation, we will provide a follow-up event that breaks down the final guidance in detail and provides insights on what its impacts will be on biostimulants producers and distributors.

Intellectual Property Portfolio Development for BioTech Startups in the Plant Space
February 2021
Mary Sylvia

Mary has nearly 30 years of experience in microbiology and patent law. Trained initially as a molecular virologist, she focuses primarily on biotech plant and pharmaceutical patent law and the development of intellectual property strategy in both procurement and litigation settings. Having served as in-house counsel, as well as working in molecular biology and genetics labs prior to law school, she brings a unique perspective to how to approach IP portfolio development strategies and the key considerations for plant developers.

Introduction to the Bioeconomy: An Interview with Stephanie Batchelor of BIO
December 2020
Martha E. Marrapese and Stephanie Batchelor

Stephanie Batchelor is an esteemed advocate for companies advancing the biobased economy. As Vice President of BIO’s Industrial and Environmental Section, Stephanie provides policy, regulatory, and strategic support and guidance to technology companies that are leaders in the production of biofuels, renewable chemicals, biobased products, and biomanufacturing processes. Martha and Stephanie engaged in an in-depth discussion on the direction of industrial biotechnology, and how the Coronavirus is no match for biotechnology and the ongoing collaboration between industry and government. 

Recent Actions by EPA’s Office of Pesticide Programs Emerging Technologies Branch
October 2020
Keith A. Matthews

EPA’s Emerging Technologies Branch in the Biopesticides and Pollution Prevention Division of the Office of Pesticide Programs has recently taken significant actions that will impact genetically engineered products under its jurisdiction. These include (1) publishing a proposed rule that would implement exemptions for plant-incorporated protectants (PIPs) from sexually compatible plants that are created through biotechnology; (2) issuing draft guidance for updating insect resistance management requirements for Lepidopteran PIPs; and (3) issuing an Experimental Use Permit for a first-of-its-kind genetically engineered mosquito that significantly diminishes the population of the mosquito vector for Zika, Dengue Fever, and Chikungunya. This webinar will discuss these actions and explain public comment opportunities for the PIPs proposed rule and draft Lepidopteran IRM guidance.