Chemical Regulation & Management

Existing and emerging law and regulation—from the federal and state governments, as well as emerging from litigation—create a challenging gauntlet for anyone manufacturing, processing, importing, selling, or distributing chemicals.  Just to start, federal regulatory programs, like the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and hazard communication requirements are different than traditional environmental regulation, which focuses on limiting the introduction of production wastes into the air, water, and land.  Instead, these programs typically apply to products and often apply throughout production, sales, distribution, and reverse distribution cycles.  KMCL Law is deeply experienced with advising clients on how to navigate these issues, both within individual regulatory programs and also challenges within the intersection of these programs.

Please contact any KMCL attorney for more information on this area of KMCL’s practice.

Pesticides

KMCL’s expertise in FIFRA matters is significant, including defending enforcement actions related to importation, composition, pesticidal claims, and registration status.  We also support registration amendment processes and provide advice about requirements on production, sales, and distribution applicable through FIFRA and FIFRA registration documents.  In short,  KMCL is adept at guiding clients through FIFRA regulatory issues and thereafter defending the subsequent use of pesticide products in the environment.

TSCA & Green Chemistry

TSCA regulates the introduction of new chemical substances into commerce and has recently been amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Among other things, this legislation requires the EPA to more actively evaluate the safety of chemical substances already being sold and distributed.  In the wake of this legislation, the EPA’s activity under TSCA has increased significantly, with a number of widely used chemical substances to be reviewed and potentially restricted.

These TSCA amendments are just a component of the “green chemistry” trend pushing toward, and in some cases requiring, the use of believed-safer substances in manufacturing processes and products. Other examples include California’s Green Chemistry Initiative, Prop 65, various EPA programs supporting the development of such alternatives, and the European Union’s directives on: (1) the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment and (2) Waste Electrical and Electronic Equipment.

KMCL Law regularly advises clients on navigating these programs and developments.

Nanotechnology

Nanotechnology (i.e, technology that makes use of nano-scale materials) are used in countless applications, from pesticides to pharmaceutical products to paint coatings, and could result in human exposures and environmental discharges.  Because nanotechnology has the potential to create novel risks to human health and the environment, it continues to attract attention from regulators and is a point of emphasis for the EPA under TSCA. Our lawyers advise companies on the evolving landscape of nanotechnology regulation.

Representative Experience

Ongoing regulatory counseling of Fortune 500 manufacturer of consumer and commercial products on FIFRA compliance, including FIFRA’s requirements applicable to “devices” and the self-disclosure to EPA of potential FIFRA violations related to a product line.

Advised international mineral mining and processing company on FIFRA compliance, particularly the applicability of FIFRA’s treated articles exemption, for an antimicrobial filler product to be sold into the decorative coatings market.

Represented international mineral mining and processing company in connection with confidential regulatory and enforcement issues arising under FIFRA.  The counterparties included EPA and a Fortune 100 global chemical manufacturer.  In connection with this matter, we obtained regulatory approval from the EPA that allowed our client to avoid several hundreds of thousands of dollars in costs.

Represent a national bird seed manufacturer on enforcement actions by both U.S. EPA and the state of California under the FIFRA.  The agencies have alleged that some of the company’s products constitute unregistered pesticides under federal and state law.

Counseled discount product manufacturer and wholesaler through FIFRA enforcement actions involving multiple states, product lines, and allegations of failure to register pesticides and mislabeling.  In the most significant enforcement action, we negotiated a resolution with EPA that allowed our client to continue marketing the product at issue as “minimal risk” and included a penalty approximately 60 percent below EPA’s proposal.

Sought “me-too” FIFRA end-use registration for a wood preservative.

Initiated a section 3 FIFRA registration for an agricultural pesticide.

Advised fabric manufacturers on acceptable antimicrobial claims.

Represent a coalition of wood treaters and pesticide manufacturers before U.S. EPA and the U.S. Occupational Safety & Health Administration on issues related to worker exposure to hexavalent chromium.

Prepared TSCA premanufacture notices for a German company.

Advised firms on possible new nanotechnology requirements.

Provided high-level regulatory and policy assistance to the manufacturer of one of the most widely used herbicides in the United States.

Assessed whether certain imported clays are subject to TSCA requirements.

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