Product Risk Management

Transportation Product Regulation

• Advising a component manufacturer client on Corporate Average Fuel Economy (CAFE) and Greenhouse Gas standards applicable to heavy duty trucks as administered by the EPA/U.S. National Highway Traffic Safety Administration (NHTSA).
• Counseled a non-road engine manufacturer regarding the ability to manufacture and distribute engines meeting older emission standards as part of an equipment replacement program.
• Advised a major heavy-duty engine manufacturer regarding new nonroad and onroad requirements promulgated by EPA.
• Counseled a first tier supplier on warranty issues regarding cracking windshields.
• Assisted an automotive component supplier with reporting a noncompliance with Federal Motor Vehicle Safety Standards (FMVSS) to NHTSA and successfully obtained a determination of inconsequent noncompliance, thus avoiding a costly recall campaign.
• Advised a component supplier regarding U.S. Coast Guard requirements applicable to shift mechanisms used in small boats, including guiding that client through a service campaign.
• Assisted a major airline carrier to comply with mandatory Customs and Border Patrol orders with respect to a quarantined plane needing treatment prior to resumption of commercial service.

Chemicals, Pesticides and Hazardous Materials

• Counseling a large technology company regarding compliance with the e-waste laws and pending legislation in various states.
• Advising a major chemical trade association's members on Occupational Safety and Health Administration's (OSHA) implementation of the Globally Harmonized System of Classification and Labeling (GHS).
• Defended a pesticide manufacturer's product from proposed EPA label modification and possible cancellation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
• Represented a pesticide manufacturer in several data compensation claims seeking payment for competitor’s use of data in  obtaining EPA registrations.
• Assisted a client in responding to California's Proposition 65 60-day notice alleging violation of requirements for labeling products including known toxins resulting in no further action.
• Represented a major transport company in an enforcement action for the alleged illegal disposal of hazardous waste.
• Represented an aircraft parts supplier in an EPA Superfund removal action involving warehouses of surplus radium-containing aircraft components.

Consumer Product Safety and Recalls

• Negotiated a pro-rated refund for affected consumers for a client undertaking a U.S. Consumer Product Safety Commission (CPSC) recall, avoiding payment of full refunds.
• Negotiated a relabeling corrective action plan with the CPSC for a client, avoiding the necessity and attendant costs of a full scale recall.
• Represented an appliance manufacturer before the CPSC and convinced the agency that no substantial product hazard existed from transformer failure, and thus avoiding the need for any corrective action.
• Performed analyses of multiple companies' entire product lines under the new Consumer Product Safety Improvement Act (CPSIA) and advised these clients on steps for compliance. Major focus included identification of products requiring compliance with the new children’s products rules and other certification rules.
• Providing counseling and representation in connection with the CPSC’s Chinese drywall investigation.
• Provide due diligence evaluations of potential acquisitions for regulatory compliance and product liability risks.
  

Food, Drug, Device, and Cosmetics Regulation

• Represented and counseled clients on a wide variety of regulatory and compliance matters covering the full range of U.S. Food and Drug Administration (FDA)-regulated products including prescription and over-the-counter (OTC) drugs, biologics, medical devices, foods, dietary supplements, animal feed and veterinary products, and cosmetics.
• Offered counseling on good manufacturing practices and quality systems regulations, FDA reporting requirements, product labeling, and product approvals. We also provided a full range of compliance services aimed at preparing clients for successful FDA inspections, including the development and evaluation of FDA compliance programs, evaluating the adequacy of Standard Operating Procedures (SOPs) and investigation reports, providing inspection management counseling and training, developing recall strategies, and assisting clients at regulatory meetings and in responding to Form FDA 483s and Warning Letters.
• Provided regulatory advice concerning corporate transactions, and conduct regulatory due diligence for corporate financing and in mergers and acquisitions. On legislative matters, we have assisted clients in development of strategies, assisted clients with testimony, prepared clients for interviews with congressional committee staff and provided advice on pending legislation.

Product Quality and Supply Chain Counseling

• Assisted manufacturer in developing process for regulatory and legal risk mitigation review and checklist from design through post-sale.
• Provided legal and regulatory risk assessment to industrial client considering a third party branding strategy of consumer goods.
• Developed product testing and quality assurance procedures with client, including drafting disclaimer and limitation of liability language for sales invoices, to reduce and shift legal risks for component supplier.

International

• Provided regulatory advice regarding the European Commission REACH (Registration, Evaluation and Authorization of Chemicals) program to a large telecom company.
• Advised clients regarding the impact of European Union (EU) Environment Health & Safety (EH&S)-driven product laws, such as Registration, Evaluation, Authorization, and Restriction of Chemical substances (REACH), Restriction of Hazardous Substance (ROHS), and the Waste Electrical and Electronic Equipment directive (WEEE).
• Advised a children products manufacturer regarding liability and regulatory issues in Europe.
• Advised U.S. importers on the U.S. Customs and Border Protection (CBP)/ CPSC Importer Self Assessment-CPSC program to reduce importation costs and increase speed to market.
• Assisted U.S. importers on CBP enforcement actions, detention, seizures and penalties related to violations of other agency regulations.
• Provided advice to clients regarding compliance with international agreements and laws related to environmental, health, safety, hazardous materials, and labor issues applicable to goods traded internationally.
• Assisted foreign manufacturers with product quality and supply chain issues to ensure compliance with U.S. and international laws.
• Assisted clients with negotiations of international agreements on environmental, health, safety, hazardous materials, and labor laws.
• Advised clients in matters before Canadian agencies that deal with product health and safety regulations, including proposed action taken under Canada’s Chemical Management Plan involving review of the 23,000 chemicals on the Domestic Substances List (DSL).

Hazmat Transportation Counseling

• Assisted a U.S. shipper in recovering a seized package abroad and successfully avoiding enforcement action.
• Defended and negotiated settlements in actions brought against airlines and shippers by the Federal and Aviation Administration (FAA).
• Assisted a liquor manufacturer respond to a letter of investigation related to a shipment.
• Advised a major U.S. manufacturer regarding international shipment of gas samples and confirming that the samples are not covered by the HMR.

Food and Beverage

• Assisted with preparing a successful response to inspectional observations (Form 483) following an establishment inspection by FDA.
• Provided advice on meeting the requirements of the latest food safety legislation, including new requirements for menu and other nutrition labeling.
• Assisted with preparing for biotechnology consultations at FDA for genetically modified food.
• Provided advice on avoiding food adulteration problems and other compliance issues relating to adulterated food.
• Provided advice on the scope and substance of FDA regulations covering food contact surfaces and guidance on complying with such requirements including:
  • Provided advice on FDA requirements for food packaging.
  • Assisted with the submission of food contact notifications.
  • Assessment of the sufficiency of testing products intended as food contact surfaces.
• Provided advice on whether new products containing specific antimicrobial and antifungal constituents are regulated by FDA as food contact substances, and if so, whether they complied with applicable FDA regulations.
• Assisted with preparing food additive petitions for submission to FDA.
• Provided advice on labeling requirements for pet food and other pet care products.
• Provided advice on safety requirements and other compliance issues for pet food and other pet care products.

Product Labeling Advice

• Provided labeling advice on sporting apparel and accessories.
• Advised on use of registration cards as precondition to warranty coverage and related warranty issues.
• Assisted client in defending U.S. Environmental Protection Agency (EPA) allegation of inappropriate use of EnergyStar logo.
• Performed legal and regulatory review of pesticide product labels, including directions for use, appropriate precautionary statements, and claims used in marketing.